Recall archive / FDA device enforcement
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.... — FDA record Z-0489-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 18, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No
- Reason
- Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
- Classification
- Class II
- Recalling firm
- Abbott Laboratories
- Quantity
- 833
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0489-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | SN UDI HQ00480 (01)380740138851(21)HQ00480 HQ01231 (01)380740138851(21)HQ01231 HQ01232 (01)380740138851(21)HQ01232 HQ01233 (01)380740138851(21)HQ01233 HQ01236 (01)380740138851(21)HQ01236 HQ01237 (01)380740138851(21)HQ01237 HQ01238 (01)380740138851(21)HQ01238 HQ01239 (01)380740138851(21)HQ01239 HQ01240 (01)380740138851(21)HQ01240 HQ01241 (01)380740138851(21)HQ01241 HQ01244 (01)380740138851(21)HQ01244 HQ01246 (01)380740138851(21)HQ01246 HQ01247 (01)380740138851(21)HQ01247 HQ01248 (01)380740138851(21)HQ01248 HQ01249 (01)380740138851(21)HQ01249 HQ01250 (01)380740138851(21)HQ01250 HQ01252 (01)380740138851(21)HQ01252 HQ01253 (01)380740138851(21)HQ01253 HQ01256 (01)380740138851(21)HQ01256 HQ01257 (01)380740138851(21)HQ01257 HQ01263 (01)380740138851(21)HQ01263 HQ01265 (01)380740138851(21)HQ01265 OUS: HQ00117 (01)380740138851(21)HQ00117 HQ00119 (01)380740138851(21)HQ00119 HQ00120 (01)380740138851(21)HQ00120 HQ00126 (01)380740138851(21)HQ00126 HQ00127 (01)380740138851(21)HQ00127 HQ00128 (01)380740138851(21)HQ00128 HQ00132 (01)380740138851(21)HQ00132 HQ00136 (01)380740138851(21)HQ00136 HQ00139 (01)380740138851(21)HQ00139 HQ00140 (01)380740138851(21)HQ00140 HQ00141 (01)380740138851(21)HQ00141 HQ00144 (01)380740138851(21)HQ00144 HQ00145 (01)380740138851(21)HQ00145 HQ00148 (01)380740138851(21)HQ00148 HQ00149 (01)380740138851(21)HQ00149 HQ00152 (01)380740138851(21)HQ00152 HQ00154 (01)380740138851(21)HQ00154 HQ00157 (01)380740138851(21)HQ00157 HQ00162 (01)380740138851(21)HQ00162 HQ00164 (01)380740138851(21)HQ00164 HQ00166 (01)380740138851(21)HQ00166 HQ00169 (01)380740138851(21)HQ00169 HQ00171 (01)380740138851(21)HQ00171 HQ00172 (01)380740138851(21)HQ00172 HQ00173 (01)380740138851(21)HQ00173 HQ00174 (01)380740138851(21)HQ00174 HQ00175 (01)380740138851(21)HQ00175 HQ00183 (01)380740138851(21)HQ00183 HQ00184 (01)380740138851(21)HQ00184 HQ00185 (01)380740138851(21)HQ00185 HQ00187 (01)380740138851(21)HQ00187 HQ00191 (01)380740138851(21)HQ00191 HQ00192 (01)380740138851(21)HQ00192 HQ00194 (01)380740138851(21)HQ00194 HQ00196 (01)380740138851(21)HQ00196 HQ00197 (01)380740138851(21)HQ00197 HQ00198 (01)380740138851(21)HQ00198 HQ00201 (01)380740138851(21)HQ00201 HQ00203 (01)380740138851(21)HQ00203 HQ00204 (01)380740138851(21)HQ00204 HQ00208 (01)380740138851(21)HQ00208 HQ00209 (01)380740138851(21)HQ00209 HQ00210 (01)380740138851(21)HQ00210 HQ00215 (01)380740138851(21)HQ00215 HQ00217 (01)380740138851(21)HQ00217 HQ00218 (01)380740138851(21)HQ00218 HQ00222 (01)380740138851(21)HQ00222 HQ00223 (01)380740138851(21)HQ00223 HQ00230 (01)380740138851(21)HQ00230 HQ00240 (01)380740138851(21)HQ00240 HQ00242 (01)380740138851(21)HQ00242 HQ00243 (01)380740138851(21)HQ00243 HQ00244 (01)380740138851(21)HQ00244 HQ00245 (01)380740138851(21)HQ00245 HQ00246 (01)380740138851(21)HQ00246 HQ00248 (01)380740138851(21)HQ00248 HQ00249 (01)380740138851(21)HQ00249 HQ00250 (01)380740138851(21)HQ00250 HQ00252 (01)380740138851(21)HQ00252 HQ00254 (01)380740138851(21)HQ00254 HQ00255 (01)380740138851(21)HQ00255 HQ00258 (01)380740138851(21)HQ00258 HQ00259 (01)380740138851(21)HQ00259 HQ00261 (01)380740138851(21)HQ00261 HQ00264 (01)380740138851(21)HQ00264 HQ00265 (01)380740138851(21)HQ00265 HQ00266 (01)380740138851(21)HQ00266 HQ00268 (01)380740138851(21)HQ00268 HQ00269 (01)380740138851(21)HQ00269 HQ00270 (01)380740138851(21)HQ00270 HQ00271 (01)380740138851(21)HQ00271 HQ00273 (01)380740138851(21)HQ00273 HQ00274 (01)380740138851(21)HQ00274 HQ00276 (01)380740138851(21)HQ00276 HQ00277 (01)380740138851(21)HQ00277 HQ00278 (01)380740138851(21)HQ00278 HQ00279 (01)380740138851(21)HQ00279 HQ00281 (01)380740138851(21)HQ00281 HQ00282 (01)380740138851(21)HQ00282 HQ00283 (01)380740138851(21)HQ00283 HQ00286 (01)380740138851(21)HQ00286 HQ00287 (01)380740138851(21)HQ00287 HQ00289 (01)380740138851(21)HQ00289 HQ00291 (01)380740138851(21)HQ00291 HQ00293 (01)380740138851(21)HQ00293 HQ00295 (01)380740138851(21)HQ00295 HQ00296 (01)380740138851(21)HQ00296 HQ00299 (01)380740138851(21)HQ00299 HQ00302 (01)380740138851(21)HQ00302 HQ00303 (01)380740138851(21)HQ00303 HQ00307 (01)380740138851(21)HQ00312 HQ00312 (01)380740138851(21)HQ00312 HQ00313 (01)380740138851(21)HQ00313 HQ00314 (01)380740138851(21)HQ00314 HQ00315 (01)380740138851(21)HQ00315 HQ00316 (01)380740138851(21)HQ00316 HQ00318 (01)380740138851(21)HQ00318 HQ00319 (01)380740138851(21)HQ00319 HQ00321 (01)380740138851(21)HQ00321 HQ00324 (01)380740138851(21)HQ00324 HQ00327 (01)380740138851(21)HQ00327 HQ00328 (01)380740138851(21)HQ00328 HQ00329 (01)380740138851(21)HQ00329 HQ00331 (01)380740138851(21)HQ00331 HQ00332 (01)380740138851(21)HQ00332 HQ00334 (01)380740138851(21)HQ00334 HQ00335 (01)380740138851(21)HQ00335 HQ00336 (01)380740138851(21)HQ00336 HQ00337 (01)380740138851(21)HQ00337 HQ00338 (01)380740138851(21)HQ00338 HQ00343 (01)380740138851(21)HQ00343 HQ00344 (01)380740138851(21)HQ00344 HQ00346 (01)380740138851(21)HQ00346 HQ00347 (01)380740138851(21)HQ00347 HQ00348 (01)380740138851(21)HQ00348 HQ00349 (01)380740138851(21)HQ00349 HQ00350 (01)380740138851(21)HQ00350 HQ00352 (01)380740138851(21)HQ00352 HQ00353 (01)380740138851(21)HQ00353 HQ00357 (01)380740138851(21)HQ00357 HQ00358 (01)380740138851(21)HQ00358 HQ00361 (01)380740138851(21)HQ00361 HQ00362 (01)380740138851(21)HQ00362 HQ00365 (01)380740138851(21)HQ00365 HQ00368 (01)380740138851(21)HQ00368 HQ00371 (01)380740138851(21)HQ00371 HQ00372 (01)380740138851(21)HQ00372 HQ00376 (01)380740138851(21)HQ00376 HQ00379 (01)380740138851(21)HQ00379 HQ00380 (01)380740138851(21)HQ00380 HQ00382 (01)380740138851(21)HQ00382 HQ00383 (01)380740138851(21)HQ00383 HQ00384 (01)380740138851(21)HQ00384 HQ00386 (01)380740138851(21)HQ00386 HQ00387 (01)380740138851(21)HQ00387 HQ00389 (01)380740138851(21)HQ00389 HQ00390 (01)380740138851(21)HQ00390 HQ00391 (01)380740138851(21)HQ00391 HQ00404 (01)380740138851(21)HQ00404 HQ00406 (01)380740138851(21)HQ00406 HQ00410 (01)380740138851(21)HQ00410 HQ00411 (01)380740138851(21)HQ00411 HQ00413 (01)380740138851(21)HQ00413 HQ00414 (01)380740138851(21)HQ00414 HQ00415 (01)380740138851(21)HQ00415 HQ00416 (01)380740138851(21)HQ00416 HQ00417 (01)380740138851(21)HQ00417 HQ00420 (01)380740138851(21)HQ00420 HQ00422 (01)380740138851(21)HQ00422 HQ00423 (01)380740138851(21)HQ00423 HQ00424 (01)380740138851(21)HQ00424 HQ00425 (01)380740138851(21)HQ00425 HQ00430 (01)380740138851(21)HQ00430 HQ00432 (01)380740138851(21)HQ00432 HQ00433 (01)380740138851(21)HQ00433 HQ00434 (01)380740138851(21)HQ00434 HQ00435 (01)380740138851(21)HQ00435 HQ00436 (01)380740138851(21)HQ00436 HQ00438 (01)380740138851(21)HQ00438 HQ00439 (01)380740138851(21)HQ00439 HQ00440 (01)380740138851(21)HQ00440 HQ00442 (01)380740138851(21)HQ00442 HQ00443 (01)380740138851(21)HQ00443 HQ00444 (01)380740138851(21)HQ00444 HQ00445 (01)380740138851(21)HQ00445 HQ00446 (01)380740138851(21)HQ00446 HQ00447 (01)380740138851(21)HQ00447 HQ00448 (01)380740138851(21)HQ00448 HQ00453 (01)380740138851(21)HQ00453 HQ00455 (01)380740138851(21)HQ00455 HQ00456 (01)380740138851(21)HQ00456 HQ00457 (01)380740138851(21)HQ00457 HQ00458 (01)380740138851(21)HQ00458 HQ00460 (01)380740138851(21)HQ00460 HQ00461 (01)380740138851(21)HQ00461 HQ00462 (01)380740138851(21)HQ00462 HQ00463 (01)380740138851(21)HQ00463 HQ00464 (01)380740138851(21)HQ00464 HQ00466 (01)380740138851(21)HQ00466 HQ00468 (01)380740138851(21)HQ00468 HQ00469 (01)380740138851(21)HQ00469 HQ00471 (01)380740138851(21)HQ00471 HQ00472 (01)380740138851(21)HQ00472 HQ00474 (01)380740138851(21)HQ00474 HQ00475 (01)380740138851(21)HQ00475 HQ00476 (01)380740138851(21)HQ00476 HQ00477 (01)380740138851(21)HQ00477 HQ00479 (01)380740138851(21)HQ00479 HQ00481 (01)380740138851(21)HQ00481 HQ00482 (01)380740138851(21)HQ00482 HQ00483 (01)380740138851(21)HQ00483 HQ00484 (01)380740138851(21)HQ00484 HQ00485 (01)380740138851(21)HQ00485 HQ00489 (01)380740138851(21)HQ00489 HQ00490 (01)380740138851(21)HQ00490 HQ00491 (01)380740138851(21)HQ00491 HQ00492 (01)380740138851(21)HQ00492 HQ00493 (01)380740138851(21)HQ00493 HQ00494 (01)380740138851(21)HQ00494 HQ00495 (01)380740138851(21)HQ00495 HQ00496 (01)380740138851(21)HQ00496 HQ00497 (01)380740138851(21)HQ00497 HQ00498 (01)380740138851(21)HQ00498 HQ00499 (01)380740138851(21)HQ00499 HQ00500 (01)380740138851(21)HQ00500 HQ00501 (01)380740138851(21)HQ00501 HQ00503 (01)380740138851(21)HQ00503 HQ00504 (01)380740138851(21)HQ00504 HQ00505 (01)380740138851(21)HQ00505 HQ00507 (01)380740138851(21)HQ00507 HQ00514 (01)380740138851(21)HQ00514 HQ00516 (01)380740138851(21)HQ00516 HQ00517 (01)380740138851(21)HQ00517 HQ00519 (01)380740138851(21)HQ00519 HQ00524 (01)380740138851(21)HQ00524 HQ00527 (01)380740138851(21)HQ00527 HQ00528 (01)380740138851(21)HQ00528 HQ00530 (01)380740138851(21)HQ00530 HQ00534 (01)380740138851(21)HQ00534 HQ00535 (01)380740138851(21)HQ00535 HQ00536 (01)380740138851(21)HQ00536 HQ00539 (01)380740138851(21)HQ00539 HQ00540 (01)380740138851(21)HQ00540 HQ00541 (01)380740138851(21)HQ00541 HQ00542 (01)380740138851(21)HQ00542 HQ00544 (01)380740138851(21)HQ00544 HQ00545 (01)380740138851(21)HQ00545 HQ00546 (01)380740138851(21)HQ00546 HQ00547 (01)380740138851(21)HQ00547 HQ00550 (01)380740138851(21)HQ00550 HQ00551 (01)380740138851(21)HQ00551 HQ00552 (01)380740138851(21)HQ00552 HQ00553 (01)380740138851(21)HQ00553 HQ00554 (01)380740138851(21)HQ00554 HQ00558 (01)380740138851(21)HQ00558 HQ00561 (01)380740138851(21)HQ00561 HQ00563 (01)380740138851(21)HQ00563 HQ00564 (01)380740138851(21)HQ00564 HQ00567 (01)380740138851(21)HQ00567 HQ00568 (01)380740138851(21)HQ00568 HQ00569 (01)380740138851(21)HQ00569 HQ00570 (01)380740138851(21)HQ00570 HQ00571 (01)380740138851(21)HQ00571 HQ00573 (01)380740138851(21)HQ00573 HQ00574 (01)380740138851(21)HQ00574 HQ00575 (01)380740138851(21)HQ00575 HQ00576 (01)380740138851(21)HQ00576 HQ00577 (01)380740138851(21)HQ00577 HQ00578 (01)380740138851(21)HQ00578 HQ00579 (01)380740138851(21)HQ00579 HQ00580 (01)380740138851(21)HQ00580 HQ00581 (01)380740138851(21)HQ00581 HQ00582 (01)380740138851(21)HQ00582 HQ00583 (01)380740138851(21)HQ00583 HQ00584 (01)380740138851(21)HQ00584 HQ00585 (01)380740138851(21)HQ00585 HQ00586 (01)380740138851(21)HQ00586 HQ00587 (01)380740138851(21)HQ00587 HQ00588 (01)380740138851(21)HQ00588 HQ00589 (01)380740138851(21)HQ00589 HQ00590 (01)380740138851(21)HQ00590 HQ00591 (01)380740138851(21)HQ00591 HQ00593 (01)380740138851(21)HQ00593 HQ00594 (01)380740138851(21)HQ00594 HQ00596 (01)380740138851(21)HQ00596 HQ00598 (01)380740138851(21)HQ00598 HQ00599 (01)380740138851(21)HQ00599 HQ00600 (01)380740138851(21)HQ00600 HQ00601 (01)380740138851(21)HQ00601 HQ00602 (01)380740138851(21)HQ00602 HQ00603 (01)380740138851(21)HQ00603 HQ00604 (01)380740138851(21)HQ00604 HQ00605 (01)380740138851(21)HQ00605 HQ00606 (01)380740138851(21)HQ00606 HQ00607 (01)380740138851(21)HQ00607 HQ00608 (01)380740138851(21)HQ00608 HQ00610 (01)380740138851(21)HQ00610 HQ00611 (01)380740138851(21)HQ00611 HQ00612 (01)380740138851(21)HQ00612 HQ00613 (01)380740138851(21)HQ00613 HQ00615 (01)380740138851(21)HQ00615 HQ00616 (01)380740138851(21)HQ00616 HQ00620 (01)380740138851(21)HQ00620 HQ00622 (01)380740138851(21)HQ00622 HQ00623 (01)380740138851(21)HQ00623 HQ00626 (01)380740138851(21)HQ00626 HQ00627 (01)380740138851(21)HQ00627 HQ00628 (01)380740138851(21)HQ00628 HQ00629 (01)380740138851(21)HQ00629 HQ00630 (01)380740138851(21)HQ00630 HQ00631 (01)380740138851(21)HQ00631 HQ00632 (01)380740138851(21)HQ00632 HQ00633 (01)380740138851(21)HQ00633 HQ00634 (01)380740138851(21)HQ00634 HQ00635 (01)380740138851(21)HQ00635 HQ00637 (01)380740138851(21)HQ00637 HQ00639 (01)380740138851(21)HQ00639 HQ00640 (01)380740138851(21)HQ00640 HQ00641 (01)380740138851(21)HQ00641 HQ00642 (01)380740138851(21)HQ00642 HQ00643 (01)380740138851(21)HQ00643 HQ00644 (01)380740138851(21)HQ00644 HQ00645 (01)380740138851(21)HQ00645 HQ00646 (01)380740138851(21)HQ00646 HQ00647 (01)380740138851(21)HQ00647 HQ00649 (01)380740138851(21)HQ00649 HQ00650 (01)380740138851(21)HQ00650 HQ00651 (01)380740138851(21)HQ00651 HQ00654 (01)380740138851(21)HQ00654 HQ00655 (01)380740138851(21)HQ00655 HQ00657 (01)380740138851(21)HQ006... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution: US (nationwide) to states of: AL, CA, CO, FL, IN, MN, NC, NY, OK and OUS (foreign) to countries of: ALBANIA, ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CAYMAN ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAMAICA, JAPAN, JORDAN, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MALDIVES, MEXICO, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, SAUDI ARABIA, SERBIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, TURKEY, UAE,UNITED KINGDOM, URUGUAY, and VIETNAM.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 19, 2025
- Recall initiation date
- Sep 18, 2025
- Center classification date
- Nov 12, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.