Z-1690-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- January 2, 2018
- Termination Date
- February 10, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
Product Description
ADVIA Centaur¿ HBc IgM
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.
Distribution Pattern
Nationwide and Canada, Mexico, and Thailand
Code Information
ADVIA Centaur¿ HBc IgM; test, hepatitis b (b core, be antigen, be antibody, b core igm); SMN 10308978 Lot codes: ADVIA Centaur aHBcM Lot # 02437164 14331164 20876164 29394164 81764164 93146164 26976167 39604167 44125167 56754167 67635167 77328167 01396170 07110170 21484170 67103170 86117170 92364170 31751171 33726171 41538171 ***Added 9/11/20*** 10308978 ***Added 11/2/20*** 62572190 ***Added 3/11/21*** 39927194