Devices

Device Recall Roche ACCUChek Voicemate Meter

Model / Serial
REF 12030802001; lot 550594A. Lancet Model 3144844001; lots M25C2, M25C5, M25C7, N32A5 and M32B5.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide.
Product Description
Roche ACCU-Chek Voicemate Meter, Roche Diagnostics, Indianapolis, IN; REF 12030802001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3144844001 (10 lancets). || The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.
Manufacturer
Roche Diagnostics Corp.
1 Event
- Recall of Device Recall Roche ACCUChek Voicemate Meter

Manufacturer

Roche Diagnostics Corp.

Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
Source
USFDA

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