Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully autom
FDA device recall Z-0064-2015 · posted 2014-10-10 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Reason for recall
- The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. In addition, the reference ranges are different when comparing with corresponding ranges listed in the Instructions for Use for the analyzer and the reference literature source.
- Action taken
- The Urgent Medical Device Correction will be sent via UPS Ground (receipt required) to the consignee list. The Urgent Medical Device Correction will be sent via UPS Ground (receipt required) to the consignee list. Consignees are instructed as follows: " Check the current set of reference values on your cobas b 221 blood gas system and, if appropriate, change the reference ranges accordingly. " If you have not established your own reference ranges, please follow the instructions in the Workaround section of the UMDC or contact the Roche Support Network Customer Support Center.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 492 devicees
- Distribution
- Nationwide Distribution including Puerto Rico and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, ME, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, PA, RI, SC
- Date initiated
- 2014-09-12
- Date posted
- 2014-10-10
- 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 |