Recall Z-1672-2018

Siemens Healthcare Diagnostics, Inc. · initiated January 2, 2018

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridge

Codes / lots: MMB, colorimetric method, cpk or isozymes, K6420, SMN# 10445097 Lot codes: 16284BD 16312BB 17011BD 17058BD 17093BC 17136BE 17186BE 17235BC 17268BA

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-1672-2018
Initiated
January 2, 2018
Posted by FDA
May 4, 2018
Terminated
February 10, 2023
Product code
JHY – Colorimetric Method, Cpk Or Isoenzymes
Distribution
Nationwide and Canada, Mexico, and Thailand
Recalling firm
Siemens Healthcare Diagnostics, Inc., Tarrytown, NY

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1668-2018 Class IIDimension 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 IIDimension 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 IIDimension 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 IIDimension 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-1673-2018 Class IIDimension 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 IIIMMULITE 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 IIIMMULITE 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 IIIMMULITE 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 IIIMMULITE /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 IIIMMULITE /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 IIIMMULITE 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 IIIMMULITE /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 IIIMMULITE 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 IIIMMULITE /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 IIIMMULITE 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 IIIMMULITE /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 IIIMMULITE 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 IIIMMULITE /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 IIADVIA Centaur CyclosporineThe concentrations for biotin listed in the non-interfering substances section of the instructions for use… 01/02/2018Terminated
Z-1688-2018 Class IIADVIA 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 IIADVIA 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 IIADVIA 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 IIIMMULITE 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