Accu-Chek Comfort Curve blood glucose test strips; (packaged in 10s, 50s, and/or 100s) U.S. Reference nos. 12030420001, 12030373001, 12030381001, 12030365001, 04388208001, 04388186001 and 03000141001.
Hazard
The drying agent beads, located in the cap, may become loose and fall into the vial causing the test strips to potentially give incorrect blood glucose test results.
What You Should Do
Remedy
U.S. consignees, point of care coordinators or laboratory managers, long term care professionals, health care professionals, pharmacists, and mail order distributors were notified via letter dated 6/28/06 to cease using the strips and to contact the firm for replacement if they see loose beads in their vial. International accounts were also notified.
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Products
Accu-Chek Comfort Curve blood glucose test strips; (packaged in 10s, 50s, and/or 100s) U.S. Reference nos. 12030420001, 12030373001, 12030381001, 12030365001, 04388208001, 04388186001 and 03000141001.
- Brand
- Roche Diagnostics Corp.
- UPC
- All lots expiring before July 31, 2007.
Units Affected
21,000,000 consumer vials and 10,000,000 hospital vials to U.S. plus 35,000,000 vials international-(Totals for Recalls Z-1377-1384-06)