cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole b...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2446-2015.
Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused by a calibration issue with the PO2 parameter. This issue may not be detected since QC results can be below mean values, but still within 2 standard deviations (SD) limits. Potential for erroneously low PO2 results in patient samples, especially in blood samples with PO2 values below 50 mmHg
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2446-2015.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- 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-2446-2015.
Roche Diagnostics Operations, Inc.
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The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
Visit FDA.gov →📣 Report an adverse event to the FDA (MedWatch)
If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Roche Diagnostics Operations, Inc. Recall FAQ
Roche Diagnostics Operations, Inc. is the subject of a respiratory devices safety report: cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole b.... The notice was published on July 14, 2015 by the U.S. Food and Drug Administration (FDA). Approximately 82 units are potentially affected.