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U.S. Department of Health and Human Services

Class 2 Device Recall Roche Ammonia/Ethanol/CO2 Calibrator

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 Class 2 Recall
Roche Ammonia/Ethanol/CO2 Calibrator
see related information
Date Posted December 29, 2007
Recall Status1 Terminated on September 22, 2009
Recall Number Z-0377-2008
Recall Event ID 45805
Premarket Notification
510(K) Number
K031880 
Product Classification Calibrator, Multi-Analyte Mixture - Product Code JIX
Product 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
Code Information Lot No: 179070-01 and 179070-02; exp. 4/30/2008.
Recalling Firm/
Manufacturer
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis, Indiana 46250-0416
Manufacturer Reason
for Recall
High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay.
FDA Determined
Cause 2
DESIGN: 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 1,904
Distribution Nationwide Distibution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JIX and Original Applicant = ROCHE DIAGNOSTICS CORP.
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