Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1678-2018 — IMMULITE ¿ /IMMULITE ¿ 1000 CEA

U.S. FDA — Device Enforcement · United States · 2018-01-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1678-2018
Date of alert
2018-01-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Healthcare Diagnostics, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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