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Terminated

ACCU-CHEK Inform base unit; catalog no. 3035131.

FDA Recall Z-1061-04 · Posted 2004-07-20

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeNBW
Date Initiated2004-06-30
Date Terminated2005-10-03

Reason for Recall

Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.

Firm Action

A recall notice dated 6/30/04 was sent to each customer instructing them on proper cleaning methods, asking them to inspect their units for damage, and providing warning stickers for attachment to the base units.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012210MODIFICATION TO ACCU-CHEK INFORM METERRoche Diagnostics Corp. · 2001-08-09K003846ACCU-CHEK INFORM METERRoche Diagnostics Corp. · 2001-03-19

Official Source

View FDA Recall →

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

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