Recall Z-0377-2008 ยท JIX Calibrator, Multi-Analyte Mixture
Roche Diagnostics Corp.
Roche Ammonia/Ethanol/CO2 Calibrator for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas c 501 clinical chemistry analyzers; Catalog No. 20751995190. Roche Diagnostics Corporation, Indianapolis, IN 46250
| Date | Dec 29, 2007 (initiated Nov 14, 2007) |
| Status | Terminated |
| Reason | High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay. |
| Root cause | Process design |
| Action | 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 produ |
| Quantity | 1,904 |
| Distribution | Nationwide Distibution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031880 | AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL Roche Diagnostics Corp., Jul 16, 2003 |