Device product
ADVIA Centaur¿ Folate (FOL)
Z-1689-2018
Product summary
- Event
- Event 79505
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1689-2018
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: ADVIA Centaur¿ Folate; acid, folic, radioimmunoassay; SMN 10310308; 10325366; 10331250 Lot codes: ADVIA Centaur Folate (REF) Lot # 03460256 09302256 81236256 09294257 30152258 ADVIA Centaur Folate (100 Test) Lot # 76793256 85114256 96368256 05299257 99361257 19045258 25443258 40856260 ADVIA Centaur Folate (500 test) Lot # 73249256 76207256 85113256 00245257 00495257 03779257 05298257 99360257 19042258 19043258 19044258 31130258 36171260
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.