Device product
Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge
Z-1671-2018
Product summary
- Event
- Event 79505
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1671-2018
Official wording
Reason: 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.
Code information: CTNI, immunoassay method, troponin subunit, K6421, SMN# 10445098 Lot codes: 16336BA 16347BD 16363BC 17032AD 17045BC 17054BD 17074BC 17093BD 17121BA 17145BE 17180BB 17193BD 17201BB 17223BA 17264BC
Distribution pattern: Nationwide and Canada, Mexico, and Thailand
Derived failure modes
-
Unknown
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.