FDAFDA · Food and drugs·Recall number Z-1315-2014
Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems: 1. 03337103001, cobas b 221<1>Roche OMNI S1 system 2. 03337111001, cobas b 221<2>Roche OMNI S2 system 3. 03337154001,cobas b 221<6>Roche OMNI S6 system 4. 03337138001, cobas b 221<4>Roche OMNI S4 system Product Usage: Usage: Blood Gas and Electrolytes Analyzer c. Classification Name: Fully automated Critical Care Analyzer for the measurement of pH, Blood gases, electrolytes, Hematocrit, hemoglobin, glucose, lactate, urea/BUN, total hemoglobin, Oxygen saturation, oxy - deoxycarboxy and methemoglobin
Published April 9, 2014 · Recall initiated: February 28, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially cause erroneous pH and/or sodium results. Other Ion parameters are not affected.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Distributor
- Worldwide Distribution - USA nationwide including PR and the country of Guam.
- Lot
- all serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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