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Terminated

ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 3332586; Ref. no. 03332586001 with meter model no. 2138930.

FDA Recall Z-1357-06 · Posted 2006-08-05

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeCGA
Date Initiated2006-06-22
Date Terminated2008-04-07
Product Quantity55,189 meters (for all Recalls Z-1354-1371-06)

Reason for Recall

The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that the test strip may be damaged or test was not performed correctly.

Firm Action

A recall notification letter dated April 24, 2006 was sent to each customer alerting them to the fact that this error code has a dual meaning. New software will be installed in all meters when it becomes available.

Root Cause

Other

Distribution Pattern

Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K930979ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEMBoehringer Mannheim Corp. · 1993-09-08

Official Source

View FDA Recall →

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

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