FDA Device

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

Hazard

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.

What You Should Do

Remedy

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.

Products

ACCU-CHEK Instant Meter; Catalog numbers 914 and 924.
Brand
Roche Diagnostics Corp.
UPC
All units.