Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical ...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0064-2015.
The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. In addition, the reference ranges are different when comparing with corresponding ranges listed in the Instructions for Use for the analyzer and the reference literature source.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0064-2015.
Recall terminated by FDA.
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- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0064-2015.
Roche Diagnostics Operations, Inc.
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Roche Diagnostics Operations, Inc. Recall FAQ
Roche Diagnostics Operations, Inc. is the subject of a diabetes devices safety report: Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical .... The notice was published on September 12, 2014 by the U.S. Food and Drug Administration (FDA). Approximately 492 units are potentially affected.