FDA Device

Accu-Chek Comfort Curve blood glucose test strips; Reference numbers 12030420001, 12030373001, 12030381001, 12030365001, 04388208001, 04388186001 and 03000141001. (Sold in the United States).

Hazard

There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings.

What You Should Do

Remedy

Notifications (letters) dated 2/10/06 were sent to healthcare professionals, retail pharmacies, hospitals and mail order firms asking them to provide their customers with information instructing the users to inspect their strip vials and to not use strips from defective vials. Mail order accounts were instructed to forward the recall notification to end users.

Products

Accu-Chek Comfort Curve blood glucose test strips; Reference numbers 12030420001, 12030373001, 12030381001, 12030365001, 04388208001, 04388186001 and 03000141001. (Sold in the United States).
Brand
Roche Diagnostics Corp.
UPC
All lots.