Recall Z-1687-2018
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
ADVIA Centaur Cyclosporine
Codes / lots: ADVIA Centaur¿ Cyclosporine; Cyclosporine; SMN 10335448 Lot codes: ADVIA Centaur CSA Lot # 38182025 64432025 98554025 58299030 25547030 30153031 77934031 97170031
Reason for recall
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere
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-1687-2018
- Initiated
- January 2, 2018
- Posted by FDA
- May 4, 2018
- Terminated
- February 10, 2023
- Product code
- MKW – Cyclosporine
- 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-1675-2018 Class II | IMMULITE 2000/IMMULITE 2000 XPi Anti HBcConcentrations 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-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 |