Recall archive / FDA device enforcement
ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Proces... — FDA record Z-0682-2024
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 Oct 19, 2023. 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
- ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
- Reason
- The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
- Classification
- Class II
- Recalling firm
- Abbott Laboratories
- Quantity
- 995 systems
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0682-2024
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 | List Number: 02P24-01 Serial Numbers / UDI Codes: C400911 (01)00380740003746(21)C400911 C402913 (01)00380740003746(21)C402913 C460004 (01)00380740003746(21)C460004 C460033 (01)00380740003746(21)C460033 C460055 (01)00380740003746(21)C460055 C460066 (01)00380740003746(21)C460066 C460082 (01)00380740003746(21)C460082 C460158 (01)00380740003746(21)C460158 C460200 (01)00380740003746(21)C460200 C460375 (01)00380740003746(21)C460375 C460385 (01)00380740003746(21)C460385 C460396 (01)00380740003746(21)C460396 C460397 (01)00380740003746(21)C460397 C460408 (01)00380740003746(21)C460408 C460410 (01)00380740003746(21)C460410 C460422 (01)00380740003746(21)C460422 C460435 (01)00380740003746(21)C460435 C460439 (01)00380740003746(21)C460439 C460523 (01)00380740003746(21)C460523 C460532 (01)00380740003746(21)C460532 C460588 (01)00380740003746(21)C460588 C460728 (01)00380740003746(21)C460728 C460767 (01)00380740003746(21)C460767 C460797 (01)00380740003746(21)C460797 C460798 (01)00380740003746(21)C460798 C460800 (01)00380740003746(21)C460800 C460826 (01)00380740003746(21)C460826 C460827 (01)00380740003746(21)C460827 C460830 (01)00380740003746(21)C460830 C460832 (01)00380740003746(21)C460832 C460833 (01)00380740003746(21)C460833 C460834 (01)00380740003746(21)C460834 C460846 (01)00380740003746(21)C460846 C460849 (01)00380740003746(21)C460849 C460857 (01)00380740003746(21)C460857 C460868 (01)00380740003746(21)C460868 C460875 (01)00380740003746(21)C460875 C460886 (01)00380740003746(21)C460886 C460927 (01)00380740003746(21)C460927 C460928 (01)00380740003746(21)C460928 C460939 (01)00380740003746(21)C460939 C460958 (01)00380740003746(21)C460958 C460993 (01)00380740003746(21)C460993 C461042 (01)00380740003746(21)C461042 C461092 (01)00380740003746(21)C461092 C461093 (01)00380740003746(21)C461093 C461100 (01)00380740003746(21)C461100 C461105 (01)00380740003746(21)C461105 C461112 (01)00380740003746(21)C461112 C461122 (01)00380740003746(21)C461122 C461124 (01)00380740003746(21)C461124 C461129 (01)00380740003746(21)C461129 C461130 (01)00380740003746(21)C461130 C461132 (01)00380740003746(21)C461132 C461133 (01)00380740003746(21)C461133 C461138 (01)00380740003746(21)C461138 C461148 (01)00380740003746(21)C461148 C461150 (01)00380740003746(21)C461150 C461151 (01)00380740003746(21)C461151 C461155 (01)00380740003746(21)C461155 C461172 (01)00380740003746(21)C461172 C461173 (01)00380740003746(21)C461173 C461175 (01)00380740003746(21)C461175 C461176 (01)00380740003746(21)C461176 C461192 (01)00380740003746(21)C461192 C461195 (01)00380740003746(21)C461195 C461208 (01)00380740003746(21)C461208 C461212 (01)00380740003746(21)C461212 C461220 (01)00380740003746(21)C461220 C461222 (01)00380740003746(21)C461222 C461247 (01)00380740003746(21)C461247 C461250 (01)00380740003746(21)C461250 C461271 (01)00380740003746(21)C461271 C461272 (01)00380740003746(21)C461272 C461408 (01)00380740003746(21)C461408 C461412 (01)00380740003746(21)C461412 C461413 (01)00380740003746(21)C461413 C461414 (01)00380740003746(21)C461414 C461420 (01)00380740003746(21)C461420 C461425 (01)00380740003746(21)C461425 C461446 (01)00380740003746(21)C461446 C461451 (01)00380740003746(21)C461451 C461453 (01)00380740003746(21)C461453 C461455 (01)00380740003746(21)C461455 C461457 (01)00380740003746(21)C461457 C461459 (01)00380740003746(21)C461459 C461462 (01)00380740003746(21)C461462 C461473 (01)00380740003746(21)C461473 C461474 (01)00380740003746(21)C461474 C461475 (01)00380740003746(21)C461475 C461476 (01)00380740003746(21)C461476 C461477 (01)00380740003746(21)C461477 C461491 (01)00380740003746(21)C461491 C461492 (01)00380740003746(21)C461492 C461495 (01)00380740003746(21)C461495 C461496 (01)00380740003746(21)C461496 C461497 (01)00380740003746(21)C461497 C461498 (01)00380740003746(21)C461498 C461528 (01)00380740003746(21)C461528 C461553 (01)00380740003746(21)C461553 C461554 (01)00380740003746(21)C461554 C461555 (01)00380740003746(21)C461555 C461562 (01)00380740003746(21)C461562 C461563 (01)00380740003746(21)C461563 C461587 (01)00380740003746(21)C461587 C461597 (01)00380740003746(21)C461597 C461598 (01)00380740003746(21)C461598 C461621 (01)00380740003746(21)C461621 C461656 (01)00380740003746(21)C461656 C461658 (01)00380740003746(21)C461658 C461659 (01)00380740003746(21)C461659 C461660 (01)00380740003746(21)C461660 C461662 (01)00380740003746(21)C461662 C461663 (01)00380740003746(21)C461663 C461664 (01)00380740003746(21)C461664 C461667 (01)00380740003746(21)C461667 C461668 (01)00380740003746(21)C461668 C461674 (01)00380740003746(21)C461674 C461675 (01)00380740003746(21)C461675 C461676 (01)00380740003746(21)C461676 C461678 (01)00380740003746(21)C461678 C461680 (01)00380740003746(21)C461680 C461683 (01)00380740003746(21)C461683 C461684 (01)00380740003746(21)C461684 C461712 (01)00380740003746(21)C461712 C461713 (01)00380740003746(21)C461713 C461714 (01)00380740003746(21)C461714 C461716 (01)00380740003746(21)C461716 C461717 (01)00380740003746(21)C461717 C461720 (01)00380740003746(21)C461720 C461721 (01)00380740003746(21)C461721 C461723 (01)00380740003746(21)C461723 C461724 (01)00380740003746(21)C461724 C461751 (01)00380740003746(21)C461751 C461752 (01)00380740003746(21)C461752 C461770 (01)00380740003746(21)C461770 C461771 (01)00380740003746(21)C461771 C461772 (01)00380740003746(21)C461772 C461781 (01)00380740003746(21)C461781 C461782 (01)00380740003746(21)C461782 C461783 (01)00380740003746(21)C461783 C461800 (01)00380740003746(21)C461800 C461801 (01)00380740003746(21)C461801 C461802 (01)00380740003746(21)C461802 C461804 (01)00380740003746(21)C461804 C461820 (01)00380740003746(21)C461820 C461822 (01)00380740003746(21)C461822 C461823 (01)00380740003746(21)C461823 C461835 (01)00380740003746(21)C461835 C461837 (01)00380740003746(21)C461837 C461839 (01)00380740003746(21)C461839 C461840 (01)00380740003746(21)C461840 C461843 (01)00380740003746(21)C461843 C461846 (01)00380740003746(21)C461846 C461847 (01)00380740003746(21)C461847 C461848 (01)00380740003746(21)C461848 C461855 (01)00380740003746(21)C461855 C461856 (01)00380740003746(21)C461856 C461857 (01)00380740003746(21)C461857 C461873 (01)00380740003746(21)C461873 C461875 (01)00380740003746(21)C461875 C461881 (01)00380740003746(21)C461881 C461894 (01)00380740003746(21)C461894 C461895 (01)00380740003746(21)C461895 C461906 (01)00380740003746(21)C461906 C461919 (01)00380740003746(21)C461919 C461924 (01)00380740003746(21)C461924 C461931 (01)00380740003746(21)C461931 C461932 (01)00380740003746(21)C461932 C461934 (01)00380740003746(21)C461934 C461958 (01)00380740003746(21)C461958 C462013 (01)00380740003746(21)C462013 C462014 (01)00380740003746(21)C462014 C462015 (01)00380740003746(21)C462015 C462070 (01)00380740003746(21)C462070 C462081 (01)00380740003746(21)C462081 C462100 (01)00380740003746(21)C462100 C462108 (01)00380740003746(21)C462108 C462109 (01)00380740003746(21)C462109 C462116 (01)00380740003746(21)C462116 C462117 (01)00380740003746(21)C462117 C462123 (01)00380740003746(21)C462123 C462134 (01)00380740003746(21)C462134 C462135 (01)00380740003746(21)C462135 C462139 (01)00380740003746(21)C462139 C462144 (01)00380740003746(21)C462144 C462154 (01)00380740003746(21)C462154 C462156 (01)00380740003746(21)C462156 C462215 (01)00380740003746(21)C462215 C462216 (01)00380740003746(21)C462216 C462217 (01)00380740003746(21)C462217 C462218 (01)00380740003746(21)C462218 C462219 (01)00380740003746(21)C462219 C462220 (01)00380740003746(21)C462220 C462222 (01)00380740003746(21)C462222 C462234 (01)00380740003746(21)C462234 C462236 (01)00380740003746(21)C462236 C462239 (01)00380740003746(21)C462239 C462240 (01)00380740003746(21)C462240 C462241 (01)00380740003746(21)C462241 C462245 (01)00380740003746(21)C462245 C462246 (01)00380740003746(21)C462246 C462247 (01)00380740003746(21)C462247 C462249 (01)00380740003746(21)C462249 C462250 (01)00380740003746(21)C462250 C462254 (01)00380740003746(21)C462254 C462255 (01)00380740003746(21)C462255 C462256 (01)00380740003746(21)C462256 C462257 (01)00380740003746(21)C462257 C462309 (01)00380740003746(21)C462309 C462312 (01)00380740003746(21)C462312 C462313 (01)00380740003746(21)C462313 C462347 (01)00380740003746(21)C462347 C462384 (01)00380740003746(21)C462384 C462386 (01)00380740003746(21)C462386 C462402 (01)00380740003746(21)C462402 C462403 (01)00380740003746(21)C462403 C462404 (01)00380740003746(21)C462404 C462434 (01)00380740003746(21)C462434 C462436 (01)00380740003746(21)C462436 C462437 (01)00380740003746(21)C462437 C462439 (01)00380740003746(21)C462439 C462441 (01)00380740003746(21)C462441 C462446 (01)00380740003746(21)C462446 C462450 (01)00380740003746(21)C462450 C462506 (01)00380740003746(21)C462506 C462536 (01)00380740003746(21)C462536 02P24-02 Serial Numbers / UDI codes: C460391 (01)00380740081225(21)C460391 C460394 (01)00380740081225(21)C460394 C460395 (01)00380740081225(21)C460395 C460430 (01)00380740081225(21)C460430 C460434 (01)00380740081225(21)C460434 C461123 (01)00380740081225(21)C461123 02P24-40 Serial Numbers / UDI codes: C400062 (01)00380740003753(21)C400062 C400251 (01)00380740003753(21)C400251 C400268 (01)00380740003753(21)C400268 C400288 (01)00380740003753(21)C400288 C400350 (01)00380740003753(21)C400350 C400392 (01)00380740003753(21)C400392 C400399 (01)00380740003753(21)C400399 C400404 (01)00380740003753(21)C400404 C400412 (01)00380740003753(21)C400412 C400416 (01)00380740003753(21)C400416 C400430 (01)00380740003753(21)C400430 C400431 (01)00380740003753(21)C400431 C400445 (01)00380740003753(21)C400445 C400479 (01)00380740003753(21)C400479 C400491 (01)00380740003753(21)C400491 C400500 (01)00380740003753(21)C400500 C400515 (01)00380740003753(21)C400515 C400552 (01)00380740003753(21)C400552 C400561 (01)00380740003753(21)C400561 C400578 (01)00380740003753(21)C400578 C400624 (01)00380740003753(21)C400624 C400660 (01)00380740003753(21)C400660 C400668 (01)00380740003753(21)C400668 C400673 (01)00380740003753(21)C400673 C400680 (01)00380740003753(21)C400680 C400686 (01)00380740003753(21)C400686 C400689 (01)00380740003753(21)C400689 C400709 (01)00380740003753(21)C400709 C400710 (01)00380740003753(21)C400710 C400716 (01)00380740003753(21)C400716 C400725 (01)00380740003753(21)C400725 C400727 (01)00380740003753(21)C400727 C400741 (01)00380740003753(21)C400741 C400749 (01)00380740003753(21)C400749 C400750 (01)00380740003753(21)C400750 C400756 (01)00380740003753(21)C400756 C400757 (01)00380740003753(21)C400757 C400760 (01)00380740003753(21)C400760 C400761 (01)00380740003753(21)C400761 C400799 (01)00380740003753(21)C400799 C400804 (01)00380740003753(21)C400804 C400809 (01)00380740003753(21)C400809 C400811 (01)00380740003753(21)C400811 C400812 (01)00380740003753(21)C400812 C400816 (01)00380740003753(21)C400816 C400818 (01)00380740003753(21)C400818 C400836 (01)00380740003753(21)C400836 C400839 (01)00380740003753(21)C400839 C400842 (01)00380740003753(21)C400842 C400844 (01)00380740003753(21)C400844 C400847 (01)00380740003753(21)C400847 C400848 (01)00380740003753(21)C400848 C400857 (01)00380740003753(21)C400857 C400861 (01)00380740003753(21)C400861 C400870 (01)00380740003753(21)C400870 C400881 (01)00380740003753(21)C400881 C400884 (01)00380740003753(21)C400884 C400890 (01)00380740003753(21)C400890 C400927 (01)00380740003753(21)C400927 C400948 (01)00380740003753(21)C400948 C400993 (01)00380740003753(21)C400993 C400994 (01)00380740003753(21)C400994 C401003 (01)00380740003753(21)C401003 C401008 (01)00380740003753(21)C401008 C401010 (01)00380740003753(21)C401010 C401025 (01)00380740003753(21)C401025 C401027 (01)00380740003753(21)C401027 C401052 (01)00380740003753(21)C401052 C401080 (01)00380740003753(21)C401080 C401082 (01)00380740003753(21)C401082 C401083 (01)00380740003753(21)C401083 C401113 (01)00380740003753(21)C401113 C401119 (01)00380740003753(21)C401119 C401131 (01)00380740003753(21)C401131 C401149 (01)00380740003753(21)C401149 C401161 (01)00380740003753(21)C401161 C401180 (01)00380740003753(21)C401180 C401181 (01)00380740003753(21)C401181 C401182 (01)00380740003753(21)C401182 C401188 (01)00380... |
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
U.S.: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV O.U.S.: Brazil
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
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- 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
Dates in the source
- Report date
- Jan 17, 2024
- Recall initiation date
- Oct 19, 2023
- Center classification date
- Jan 8, 2024
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.