CLASS II Device recall · Reported 9 Apr 2014 · FDA Enforcement Report
Omni Micro-electrode/reference electrode for cobas b221 analyzer recalled
Roche Diagnostics Operations is recalling Omni Micro-electrode/reference electrode for cobas b221 analyzer, distributed nationwide in the US. The recall was initiated on 28 Feb 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1315-2014
- FDA event ID
- 67549
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Feb 2014
- FDA classified
- 1 Apr 2014
- Reported
- 9 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 28 Feb 2014 | Recall initiated by company | |
| 1 Apr 2014 | Classified by FDA | +32 days |
| 9 Apr 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution - USA nationwide including PR and the country of Guam.
Questions about this recall
Is Omni Micro-electrode/reference electrode for cobas b221 analyzer recalled?
Yes. Roche Diagnostics Operations recalled Omni Micro-electrode/reference electrode for cobas b221 analyzer on 28 Feb 2014. The recall is Class II and its status is Terminated. Recall number Z-1315-2014.
Why was it 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.
Which lots are affected?
all serial numbers
Where was it sold?
Worldwide Distribution - USA nationwide including PR and the country of Guam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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