Z-0378-2008

Roche Ammonia/Ethanol/CO2 Control N (Normal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas...

Name: Z-0378-2008 Roche Ammonia/Ethanol/CO2 Control N (Normal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas...
Creator: Roche Diagnostics Corp.
Published: 2007-11-14
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2007-11-14 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Corp. began a recall of 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... on 2007-11-14. The reason FDA records is "High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0378-2008
Status: Terminated
Initiated: 2007-11-14
Posted: 2007-12-29
Terminated: 2009-09-22
Recalling firm: Roche Diagnostics GmbH
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
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay.
Root cause tag: manufacturing process
FDA 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 product via letter dated .
Quantity in commerce: 811
Distribution: Nationwide Distibution
Product codes and lots: Lot No: 178993-01 and 178993-02; exp. 3/31/2008.

Product code JJY

K031880Class IIAmmonia/ethanol/co2 Calibrator, Control Normal, Control AbnormalRoche Diagnostics Corp. / cleared 2003-07-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)