Z-1670-2018 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
- N/A
Product Description
Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
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
SIRO, sirolimus test system, DF306, SMN# 10464331 Lot codes: BB7336 FA8037 FA8081 BB8167 FB8177 FB8219