—#38940

Product

ACCU-CHEK Instant Meter; Catalog numbers 914 and 924.

FDA product code: CGA — Glucose Oxidase, Glucose
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K952875
Affected lot / code info: All units.

Why it was recalled

The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards while the meter is waiting for the sample or if the test strip opening has been previously flooded with excess control solution or blood.

Root cause (FDA determination)

Other

Action the firm took

A recall letter dated 5/18/05 was sent to health care professionals informing them of the problem and reqeusting them to provide a letter to their patients alerting them to the issue and how to avoid it. A notice of the problem will be placed in all packages of strips in the future.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2005-05-18
Posted by FDA: 2005-07-13
Terminated: 2006-02-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #38940. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.