FDA Device

Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373, 2030381, 3000133 and 3000141.

Hazard

Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.

What You Should Do

Remedy

Urgent Product Correction letters dated 2/12/03 were issued to pharmacists, specific health care providers, and the laboratory manager at customer accounts. Letter recipients were asked to advise their patients to inspect their vial for a crack prior to each use.

Products

Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373, 2030381, 3000133 and 3000141.
Brand
Roche Diagnostics Corp.
UPC
All lots.