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Terminated

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

FDA Recall Z-0978-05 · Posted 2005-07-13

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeCGA
Date Initiated2005-05-18
Date Terminated2006-02-26

Reason for Recall

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K952875ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPSBoehringer Mannheim Corp. · 1995-11-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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