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Terminated

Roche brand AccuData GTS System; Catalog number 404, material number 03136833001.

FDA Recall Z-0882-05 · Posted 2005-06-11

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeCGA
Date Initiated2005-04-18
Date Terminated2006-03-07

Reason for Recall

If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the A/C adaptor without batteries.

Firm Action

Consignees were notified via letter dated 4/18/05, which included instructions on how to inspect their unit for damage, and how to prevent future damage.

Root Cause

Other

Distribution Pattern

Nationwide and Guam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K924475ACCUDATA GLUCOSE TEST STATIONBoehringer Mannheim Corp. · 1992-10-13

Official Source

View FDA Recall →

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

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