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

Recall Z-1610-2018 — cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, ur

U.S. FDA — Device Enforcement · United States · 2018-02-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1610-2018
Date of alert
2018-02-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Diagnostics Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
3337111001
Reported risk: The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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