Reported Apr 9, 2014 · Terminated
Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of…
Roche Diagnostics Operations, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
5 of 5 products
| # | Product as published |
|---|---|
| 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 |
| 5 | 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 |
- Lot codes and dates
- all serial numbers
- Amount recalled
- N/A
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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