Roche Diagnostics Corp. Roche Ammonia/Ethanol/CO2 Control N (Normal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas c 501 clinical chemistry analyzers; Catalog. No. 20752401190. Roche Diagnostics Corporation, Indianapolis, IN 46250 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Roche Ammonia/Ethanol/CO2 Control N (Normal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas c 501 clinical chemistry analyzers; Catalog. No. 20752401190. Roche Diagnostics Corporation, Indianapolis, IN 46250
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
Lot No: 178993-01 and 178993-02, exp. 3/31/2008.
Products Sold
Lot No: 178993-01 and 178993-02; exp. 3/31/2008.
Roche Diagnostics Corp. is recalling Roche Ammonia/Ethanol/CO2 Control N (Normal) for use in conjunction with Roche/Hitachi, COBAS INTEGR due to High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay.
Recommended Action
Per FDA guidance
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 .
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026