Recall archive / FDA device enforcement
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody. — FDA record Z-1887-2024
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 Apr 23, 2024. 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
- IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.
- Reason
- The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab.
- Classification
- Class II
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 488 units (33 US, 455 OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1887-2024
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 | Catalog # L2KTG6, SMN 10381655, UDI/DI: 00630414962115, Lot #s: 785, 790, 791, 793. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution including in the states of AL, CA, DC, FL, HI, ID, IN, KS, KY MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, PR, TX, WA WI and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Ecuador, Finland, France, Germany, Greece Guatemala, Honduras, Hong Kong, Hungary, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Norway, P.R. China, Pakistan, Paraguay, Peru, Poland, Portugal, Republic South Korea, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Taiwan, Tunisia, Turkey, Turkmenistan, Ukraine, United Kingdom, Uruguay, 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
- May 29, 2024
- Recall initiation date
- Apr 23, 2024
- Center classification date
- May 23, 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.