Z-0328-04

Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591

Name: Z-0328-04 Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591
Creator: Roche Diagnostics Corp.
Published: 2003-12-15
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2003-12-15 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591 on 2003-12-15. The reason FDA records is "If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0328-04
Status: Terminated
Initiated: 2003-12-15
Posted: 2004-01-10
Terminated: 2004-08-02
Recalling firm: Roche Diagnostics GmbH
Product: Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.
FDA root cause: Other
Action: Consignees were notified by letter mailed on or about December 15, 2003. Customers are instructed to assure an adequate sample volume until new software becomes available.
Distribution: United States.
Product codes and lots: All units with software version 5.61 or below.

Product code JJE

K972733Class IIAvl Omni AnalyzerAvl Scientific Corp. / cleared 1997-09-09

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)