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Terminated

ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter.

FDA Recall Z-1370-05 · Posted 2005-08-13

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeNBW
Date Initiated2005-06-07
Date Terminated2007-07-02
Product Quantity2490

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, and held upwards, while the meter is waiting for the sample.

Firm Action

Recall letters dated 6/7/05 were sent to all customers. Distributors were requested to send a copy of the notification to all customers of test strips used with the product. Users are instructed to never operate the meter without the optics cover in place, and this information will be included in test strip boxes.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040796ACCU-CHEK GO SYSTEMRoche Diagnostics Corp. · 2004-04-22

Official Source

View FDA Recall →

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

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