Recalls / —

—#26006

Product

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

FDA product code

LFR — Glucose Dehydrogenase, Glucose

Device class

Class 2

Medical specialty

Clinical Chemistry

510(k) numbers

K010362, K982002

Affected lot / code info

All lots.

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Roche Diagnostics Corp.

Address

9115 Hague Road, Indianapolis, Indiana 46250-0457

Distribution

Distribution pattern

United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Guatemala, Honduras, Hong Kong, Indonesia, Japan, Malaysia, Mexico, New Zealand, Norway, Pakistan, Peru, Philippines, Portugal, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom and Vietnam.

Timeline

Recall initiated

2003-02-12

Posted by FDA

2003-04-09

Terminated

2003-09-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #26006. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.