Z-1315-2014 Class II Terminated
FDA device recall Z-1315-2014 was initiated by Roche Diagnostics Operations, Inc. on Feb 28, 2014 and is designated Class II. 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. The recall status is terminated (terminated Jan 10, 2018).
Recall Details
- Product Type
- Devices
- Report Date
- Apr 9, 2014
- Initiation Date
- Feb 28, 2014
- Termination Date
- Jan 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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
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.
Distribution Pattern
Worldwide Distribution - USA nationwide including PR and the country of Guam.
Code Information
all serial numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1315-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026