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Terminated

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

FDA Recall Z-0377-2008 · Posted 2007-12-29

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeJIX
Date Initiated2007-11-14
Date Terminated2009-09-22
Product Quantity1,904

Reason for Recall

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

Firm 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 .

Root Cause

Process design

Distribution Pattern

Nationwide Distibution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031880AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMALRoche Diagnostics Corp. · 2003-07-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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