Z-1119-04

COBAS TaqMan Analyzer

Name: Z-1119-04 COBAS TaqMan Analyzer
Creator: Roche Molecular Systems Inc
Published: 2004-05-24
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2004-05-24 / Terminated

FDA source

Roche Molecular Systems Inc began a recall of COBAS TaqMan Analyzer on 2004-05-24. The reason FDA records is "Improper seating of a fiber optic cable which may cause pixel cross-talk leading to falsely elevated test results or cases of misalignment to sample-to-result mismatch". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1119-04
Status: Terminated
Initiated: 2004-05-24
Posted: 2004-07-27
Terminated: 2006-03-08
Recalling firm: Roche Molecular Systems Inc
Product: COBAS TaqMan Analyzer
Product code: JJF Analyzer, Chemistry, Micro, For Clinical Use
Reason for recall: Improper seating of a fiber optic cable which may cause pixel cross-talk leading to falsely elevated test results or cases of misalignment to sample-to-result mismatch.
FDA root cause: Other
Action: An Urgent Product Recall letter was sent to all customers with a COBAS TaqMan 96 and 48 analyzer on 5/24/2004 by overnight delivery with delivery confirmation. On May 25, 2004, All Roche Field Service Engineers were instructed to inspect the analyzers to confirm that the cables were properly seated.
Quantity in commerce: 34
Distribution: Units are sold to hospitals, clinics, and clinical laboratories thoughout the US. There are 10 VA hospitals. There is one government agency, NIH, Bethesda, MD.
Product codes and lots: COBAS TaqMan Analyzer Serial Numbers: 381046; 381053; 391159; 391166; 391181; 371036; 391130; 391095; 381052; 391191; 391096; 381044; 391131; 381050; 381054; 391180; 381045; 391177; 391189; 381047; 381051; 381055; 391182; 391157; 391148; 391135; 391143; 391141; 391138; 391175; 391144; 391161; 391150; 391156.

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)