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Devices
Device Recall N acetylprocainamide reagent
Model / Serial
14456200
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution: USA states of AL, CT, NY, PA, and TX.
Product Description
ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagnostics Corporation Indianapolis, IN.
Manufacturer
Roche Diagnostics Operations, Inc.
1 Event
Recall of Device Recall N acetylprocainamide reagent
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Manufacturer
Roche Diagnostics Operations, Inc.
Manufacturer Address
Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA
Language
English
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