Z-0917-03

COBAS TaqMan analyzer, Series 96; catalog number 8080216

Name: Z-0917-03 COBAS TaqMan analyzer, Series 96; catalog number 8080216
Creator: Roche Molecular Systems Inc
Published: 2003-03-06
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2003-03-06 / Terminated

FDA source

Roche Molecular Systems Inc began a recall of COBAS TaqMan analyzer, Series 96; catalog number 8080216 on 2003-03-06. The reason FDA records is "A false positive result may be reported". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0917-03
Status: Terminated
Initiated: 2003-03-06
Posted: 2003-06-05
Terminated: 2003-12-10
Recalling firm: Roche Molecular Systems Inc
Product: COBAS TaqMan analyzer, Series 96; catalog number 8080216.
Product code: JJF Analyzer, Chemistry, Micro, For Clinical Use
Reason for recall: A false positive result may be reported.
FDA root cause: Other
Action: Each customer was informed of the recall by telephone on March 6, 2003. Customers were instructed to check each postiive result to see if the 'RFITOOLOW' flag was generated, and follow-up instructions were provided. A recall letter was also faxed and mailed to each customer on March 6, 2003.
Quantity in commerce: 16
Distribution: Nationwide. California, Colorado, Georgia, Illinois, Maryland, Missouri, New Jersey, New Mexico, North Carolina, Utah and Virginia.
Product codes and lots: All units with software versions TaqLink v 1.0 or TaqLink v 1.1.

Product code JJF

K012966Class IRoche Cobas Taqman AnalyzerRoche Molecular Systems, Inc. / cleared 2002-02-01

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)