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

Recall Z-2330-2015 — S2 Fluid Pack on the Cobas b 221 system- Catalog Number 03260925184 Blood Gas and Electrolytes Analyzer; 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, hemato

U.S. FDA — Device Enforcement · United States · 2015-06-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2330-2015
Date of alert: 2015-06-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Roche Diagnostics Operations, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 03260925184

Reported risk: The affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to the cobas b 221 system. The error prevents the fluid from being recognized by the system and the instrument cannot start measurements until the affected S2 Fluid Pack is replaced.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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