Roche Ammonia/Ethanol/CO2 Calibrator for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas c 50
FDA device recall Z-0377-2008 · posted 2007-12-29 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay.
- Action taken
- Consignees were notified of this recall by an Urgent Medical Device Recall letter sent on 11/14/07. The letter instructed the users to immediately discontinue use of Ammonia/ Ethanol/CO2 Control N and Ammonia/Ethanol/CO2 Control A (with listed lots) for quality control assessment of the bicarbonate assay. They were informed that controls may still be used to assess ammonia and ethanol, but alternative controls must be used for assessment of the bicarbonate assay. Consignees are instructed to destroy products at their facility. Consignees were notified of the availability of replacement product via letter dated .
- Root cause
- Process design
- Status
- Terminated
- Product code
- JIX
- Quantity affected
- 1,904
- Distribution
- Nationwide Distibution
- Date initiated
- 2007-11-14
- Date posted
- 2007-12-29
- Date terminated
- 2009-09-22
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL (K031880) | Roche Diagnostics Corp. | 2003-07-16 |