Devices

in2it (I) and (II) Test Cartridges

Model / Serial
Product code LCP,expiration dates between 2011-07-12 and 2011-07-26. Kit lot numbers (I):072T97, 072T98, 072T100, (II): 074P75, 074P73, Device lot numbers 131Q203 38864, 131Q204 39008, 131Q206 39088
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA and countries including: Australia, New Zealand, Taiwan, France, the UK, Singapore, Germany, Italy, Thailand, China, Korea, Sweden, Sri Lanka, Maldives, Canada and the Philippines.
Product Description
in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges (Catalog 281-0001), manufactured by Bio-Rad Laboratories Deeside Ltd., Flintshire, UK, distributed by Bio-Rad Laboratories, Hercules, CA. || The in2it (I) is for Physician use, the (II) is for prescription home use. The products are medical devices used in affinity chromatography method, intended for the in-vitro quantitative determination of A1c (HbA1C) in capillary blood taken from a finger prick. The test is indicated for monitoring the time averaged blood glucose levels of known diabetics, for professional use as an indicator of overall glycemic control.
Manufacturer
Bio-Rad Laboratories Inc
1 Event
- Recall of in2it (I) and (II) Test Cartridges

Manufacturer

Bio-Rad Laboratories Inc

Manufacturer Address
Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
Source
USFDA

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