Device product
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 3g Allergy specific IgE Universal Kit
Z-1674-2018
Product summary
- Event
- Event 79505
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1674-2018
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: 3g Allergy specific IgE Universal kit, 3g Allergy specific IgE Universal kit (IMMULITE 2000/IMMULITE 2000 XPi L2KUN6 (D)) Lot codes: 3g Allergy Specific IgE Lot # 461 462 463 464 465 466 467 468 469 470 471 472 473 475 476 3g Allergy Specific IgE Lot # D463 D464 D465 D466 D467 D469 D471 D472 D476 D483
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.