—#66185

Product

Roche Ammonia/Ethanol/CO2 Control A (Abnormal) for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas 46250 c 501 clinical chemistry analyzers; Cat. Number. 20753009190. Roche Diagnostics Corporation, Indianapolis, IN

FDA product code: JJY — Multi-Analyte Controls, All Kinds (Assayed)
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K031880
Affected lot / code info: Lots No: 179021-01 and 179021-02; exp. 3/31/2008.

Why it was recalled

High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay.

Root cause (FDA determination)

Process design

Action the firm took

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 .

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46250-0416

Distribution

Distribution pattern: Nationwide Distibution

Timeline

Recall initiated: 2007-11-14
Posted by FDA: 2007-12-29
Terminated: 2009-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66185. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.