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Devices
Device Recall ACCUCHEK Comfort Curve Advantage
Model / Serial
All units.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands.
Product Description
ACCU-CHEK Comfort Curve, Cat. No. 2139634. Ref. numbers 03856348001 and 12139642001 both with meter model number 2138930.
Manufacturer
Roche Diagnostics Corp.
1 Event
Recall of Device Recall ACCUCHEK Comfort Curve Advantage
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Manufacturer
Roche Diagnostics Corp.
Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46250-0416
Source
USFDA
Language
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