IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
Reported: May 16, 2018 Initiated: January 2, 2018 #Z-1675-2018
Product Description
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- N/A
- Distribution
- Nationwide and Canada, Mexico, and Thailand
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: N/A.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 16, 2018. Severity: Moderate. Recall number: Z-1675-2018.
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