Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

COBAS TaqMan analyzer, Series 96; catalog number 8080216.

FDA Recall Z-0917-03 · Posted 2003-06-05

Recalling FirmRoche Molecular Systems Inc
Recall StatusTerminated
Product CodeJJF
Date Initiated2003-03-06
Date Terminated2003-12-10
Product Quantity16

Reason for Recall

A false positive result may be reported.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide. California, Colorado, Georgia, Illinois, Maryland, Missouri, New Jersey, New Mexico, North Carolina, Utah and Virginia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012966ROCHE COBAS TAQMAN ANALYZERRoche Molecular Systems, Inc. · 2002-02-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑