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Devices
ACCU-CHEK Inform meter; catalog No. 3035123.
Model / Serial
All units with firmware version 2.3 that have the OTE (other test entry) functionality enabled.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide.
Product Description
ACCU-CHEK Inform meter; catalog No. 3035123.
Manufacturer
Roche Diagnostics Corp.
1 Event
Recall of ACCU-CHEK Inform meter; catalog No. 3035123.
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Manufacturer
Roche Diagnostics Corp.
Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
Source
USFDA
Language
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