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Devices
Device Recall Roche Ammonia/Ethanol/CO2 Control A
Model / Serial
Lots No: 179021-01 and 179021-02; exp. 3/31/2008.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distibution
Product Description
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
Manufacturer
Roche Diagnostics Corp.
1 Event
Recall of Device Recall Roche Ammonia/Ethanol/CO2 Control A
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Manufacturer
Roche Diagnostics Corp.
Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46250-0416
Source
USFDA
Language
English
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