Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of th
FDA device recall Z-1315-2014 · posted 2014-04-02 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- 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.
- Action taken
- Roche Diagnostics Operations sent an Urgent Medical Device Correction letter dated February 27, 2014 via UPS Ground (receipt required) to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the enclosed fax form and fax it to 1-888-345-0253. For questions contact Roche Customer Business Support Center at 1-800-428-5076.
- Root cause
- Device Design
- Status
- Terminated
- Distribution
- Worldwide Distribution - USA nationwide including PR and the country of Guam.
- Date initiated
- 2014-02-28
- Date posted
- 2014-04-02
- Date terminated
- 2018-01-10
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ROCHE DIAGNOSTICS OMNI S ANALYZER (K032311) | Roche Diagnostics Corp. | 2003-10-17 |