Z-1428-04

Roche/Hitachi 747 - 100 clinical chemistry analyzer; catalog number 04009223680

Name: Z-1428-04 Roche/Hitachi 747 - 100 clinical chemistry analyzer; catalog number 04009223680
Creator: Roche Diagnostics Corp.
Published: 2004-08-06
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2004-08-06 / Terminated / root cause: software

FDA source

Roche Diagnostics Corp. began a recall of Roche/Hitachi 747 - 100 clinical chemistry analyzer; catalog number 04009223680 on 2004-08-06. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1428-04
Status: Terminated
Initiated: 2004-08-06
Posted: 2004-09-02
Terminated: 2006-06-26
Recalling firm: Roche Diagnostics GmbH
Product: Roche/Hitachi 747 - 100 clinical chemistry analyzer; catalog number 04009223680.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: software
FDA root cause: Other
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.
Quantity in commerce: 254
Distribution: United States.
Product codes and lots: All units.

Product code JJE

K901003Class IBoehringer Mannheim/hitachi 747 Chemistry AnalyzerBoehringer Mannheim Corp. / cleared 1990-04-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)