| Date Recall Initiated: |
May 24, 2004 |
|---|---|
| Product: | Roche COBAS TaqMan and TaqMan 48 Analyzers. |
| Use: | The COBAS TaqMan and TaqMan 48 analyzers are intended to be used by laboratory professionals. The analyzers are used for the measurement of Hepatitis B and Hepatitis C viruses and for other in-house diagnostic testing. |
| Recalling Firm: |
Roche Molecular Systems, Inc. 11 Franklin Avenue Belleville, N.J. 07109-3501 |
| Reason for Recall: |
The analyzers produced inaccurate test results. Falsely elevated values were reported due to the improper seating of a fiber optic cable in the analyzer instrument. |
Public Contact: |
Karen McCullough Director, Quality Systems Compliance Roche Molecular Systems, Inc. 908-253-7610 |
| FDA District: |
New Jersey |
| FDA Comment: |
FDA considers that the probability of life threatening consequences is likely to occur by the malfunctioning of these devices. Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death. |
For additional information on this product recall, see the Roche press release. Also, for additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2004/ENF00859.html. Scroll down to "Recalls and Field Corrections: Devices – Class I". |
Updated September 2, 2004
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH
