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

Recall Z-0060-2019 — VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793

U.S. FDA — Device Enforcement · United States · 2018-07-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0060-2019
Date of alert
2018-07-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ortho Clinical Diagnostics Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10758750000111
Reported risk: The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.
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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