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Terminated

Roche/Hitachi Modular Analytical D Module clinical chemistry analyzer; catalog number 03739023001.

FDA Recall Z-1429-04 · Posted 2004-09-02

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeJJE
Date Initiated2004-08-06
Date Terminated2006-06-26
Product Quantity138

Reason for Recall

A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions.

Firm Action

Recall letters dated 8/6/04 were sent to each customer advising them of the problem and giving instructions on how to avoid it.

Root Cause

Other

Distribution Pattern

United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K953239BOEHRINGER MANNHEIM/HITACHI 917 ANALYZERBoehringer Mannheim Corp. · 1995-09-25

Official Source

View FDA Recall →

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

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