Roche/Hitachi 747 - 100 clinical chemistry analyzer; catalog number 04009223680.
FDA Recall Z-1428-04 · Posted 2004-09-02
Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeJJE
Date Initiated2004-08-06
Date Terminated2006-06-26
Product Quantity254
Reason for Recall
A software defect will allow the reporting out of believable, but clinically significant, erroneous results if the analyzer is in operation and a channel has been masked or not requested over a period of time.
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.