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

Recall Z-1834-2020 — VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468

U.S. FDA — Device Enforcement · United States · 2020-03-10 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1834-2020
Date of alert
2020-03-10
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Ortho Clinical Diagnostics
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10758750005147
Reported risk: The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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