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
This recall has been terminated (originally issued December 29, 2007).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- November 14, 2007
- Posted
- December 29, 2007
- Terminated
- September 22, 2009
- Recall Number
- Z-0377-2008
- Quantity
- 1,904
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay.
Distribution
Nationwide Distibution
Lot / Code Info
Lot No: 179070-01 and 179070-02; exp. 4/30/2008.
Root Cause
Process design
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 .