Z-0333-04

Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and GD0395R

Name: Z-0333-04 Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and GD0395R
Creator: Roche Diagnostics Corp.
Published: 2003-12-29
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2003-12-29 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and GD0395R on 2003-12-29. The reason FDA records is "The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0333-04
Status: Terminated
Initiated: 2003-12-29
Posted: 2004-07-20
Terminated: 2004-02-20
Recalling firm: Roche Diagnostics GmbH
Product: Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and GD0395R.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.
FDA root cause: Other
Action: A recall letter dated 12/29/03 was issued to each customer instructing them not to use the listed sample types.
Distribution: United States.
Product codes and lots: All units.

Product code JJE

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)