Recall Z-1675-2018
Siemens Healthcare Diagnostics, Inc. · initiated January 2, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
IMMULITE 2000/IMMULITE 2000 XPi Anti HBc
Codes / lots: Anti HBc, Anti HBc (IMMULITE 2000/IMMULITE 2000 XPi L2KHC2 (D)) Lot codes: Anti HBcM # 579 580 581 D579 D580 D581 ***Added 9/11/20*** D602
Reason for recall
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
FDA-determined cause: Error in labeling
Action taken
Siemens Healthcare Diagnostics issued a recall in March 2017 for products with incorrect units for biotin in the Instructions for Use. After further investigation, recalling firm determined that more Siemens products also had missing or incorrect information in the IFUs for which two recalls were initiated, and Amended Corrections and Removals Reports were submitted to the FDA
Details
- Recall number
- Z-1675-2018
- Initiated
- January 2, 2018
- Posted by FDA
- May 4, 2018
- Terminated
- February 10, 2023
- Product code
- LOM – Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Distribution
- Nationwide and Canada, Mexico, and Thailand
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Tarrytown, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1668-2018 Class II | Dimension Thyroid Stimulating Hormone (TSHL) Flex reagent cartridgeThe concentrations for biotin listed in the non-interfering substances section of the instructions for use… | 01/02/2018Terminated |
| Z-1669-2018 Class II | Dimension Free Thyroxine (FT4L) Flex reagent cartridgeThe concentrations for biotin listed in the non-interfering substances section of the instructions for use… | 01/02/2018Terminated |
| Z-1670-2018 Class II | Dimension Sirolimus (SIRO) Flex reagent cartridgeConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | 01/02/2018Terminated |
| Z-1671-2018 Class II | Dimension Vista Cardiac Troponin I (CTNI) Flex reagent cartridgeConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | 01/02/2018Terminated |
| Z-1672-2018 Class II | Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridgeConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | 01/02/2018Terminated |
| Z-1673-2018 Class II | Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridgeThe concentrations for biotin listed in the non-interfering substances section of the instructions for use… | 01/02/2018Terminated |
| Z-1674-2018 Class II | IMMULITE 2000/IMMULITE 2000 XPi 3g Allergy specific IgE Universal KitConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | 01/02/2018Terminated |
| Z-1676-2018 Class II | IMMULITE 2000/IMMULITE 2000 XPi Folic AcidConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | 01/02/2018Terminated |
| Z-1677-2018 Class II | IMMULITE /IMMULITE 1000 BR-MA (CA15-3)Concentrations for the level of biotin that does not interfere is not currently listed in the instruction… | 01/02/2018Terminated |
| Z-1678-2018 Class II | IMMULITE /IMMULITE 1000 CEAConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | 01/02/2018Terminated |
| Z-1679-2018 Class II | IMMULITE 2000/IMMULITE 2000 XPi CEAConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | 01/02/2018Terminated |
| Z-1680-2018 Class II | IMMULITE /IMMULITE 1000 GastrinConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | 01/02/2018Terminated |
| Z-1681-2018 Class II | IMMULITE 2000/IMMULITE 2000 XPi GastrinConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | 01/02/2018Terminated |
| Z-1682-2018 Class II | IMMULITE /IMMULITE 1000 OM-MA (CA125)Concentrations for the level of biotin that does not interfere is not currently listed in the instruction… | 01/02/2018Terminated |
| Z-1683-2018 Class II | IMMULITE 2000/IMMULITE 2000 XPi OM-MA (CA125)Concentrations for the level of biotin that does not interfere is not currently listed in the instruction… | 01/02/2018Terminated |
| Z-1684-2018 Class II | IMMULITE /IMMULITE 1000 TGConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | 01/02/2018Terminated |
| Z-1685-2018 Class II | IMMULITE 2000/IMMULITE 2000 XPi TGConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | 01/02/2018Terminated |
| Z-1686-2018 Class II | IMMULITE /IMMULITE 1000 Vitamin B12Concentrations for the level of biotin that does not interfere is not currently listed in the instruction… | 01/02/2018Terminated |
| Z-1687-2018 Class II | ADVIA Centaur CyclosporineThe concentrations for biotin listed in the non-interfering substances section of the instructions for use… | 01/02/2018Terminated |
| Z-1688-2018 Class II | ADVIA Centaur DHEA-SO4The concentrations for biotin listed in the non-interfering substances section of the instructions for use… | 01/02/2018Terminated |
| Z-1689-2018 Class II | ADVIA Centaur Folate (FOL)Concentrations for the level of biotin that does not interfere is not currently listed in the instruction… | 01/02/2018Terminated |
| Z-1690-2018 Class II | ADVIA Centaur HBc IgMConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | 01/02/2018Terminated |
| Z-1691-2018 Class II | IMMULITE 2000/IMMULITE 2000 XPi BR-MA (CA15-3)Concentrations for the level of biotin that does not interfere is not currently listed in the instruction… | 01/02/2018Terminated |