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

Recall Z-1113-2022 — VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198

U.S. FDA — Device Enforcement · United States · 2022-03-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1113-2022
Date of alert
2022-03-25
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)
10758750008902
Reported risk: Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.
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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