Devices

Device Recall FreeStyle and FreeStyle Lite Blood Glucose Monitoring Test Strips

Model / Serial
Part number/Lot or Serial Number/Expiration dates: 70345-02, 70468-1/0803221/Feb 2010; 70468-05/0802523/Jan 2010; 70344-02/0802832, 0802823, 0802422/JAN 2010, 70827-01/0817617/Jun 2010; 70468-04/0718730/ July 2009; 70817-01/0812304/May 2010
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
The firm, ADC, quarantined the eight lots and disposed them to scrap. These eight lots were not released from the firm ADC's control; therefore, the firm was unable to determine the number of consignees.
Product Description
FreeStyle Blood Glucose Monitoring System Test Strips and Freestyle Lite Blood Glucose Monitoring System Test Strips, for use with FreeStyle and FreeStyle Lite Test Strips respectively, 100 count, manufactured by Abbott Diabetes Care, Alameda, CA. || Product is used with FreeStyle and FreeStyle Lite Blood Glucose Meters to measure glucose (sugar) in whole blood. The test strips are used for testing outside the body (in vitro diagnostic use). The FreeStyle Blood Glucose Monitoring Systems are intended for use in the home and in professional settings to monitor blood glucose levels.
Manufacturer
Abbott Diabetes Care, Inc.
1 Event
- Recall of Device Recall FreeStyle and FreeStyle Lite Blood Glucose Monitoring Test Strips

Manufacturer

Abbott Diabetes Care, Inc.

Manufacturer Address
Abbott Diabetes Care, Inc., 1360 S Loop Rd, Alameda CA 94502-7000
Source
USFDA

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