Recall Z-0917-03 ยท JJF Analyzer, Chemistry, Micro, For Clinical Use
Roche Molecular Systems Inc
COBAS TaqMan analyzer, Series 96; catalog number 8080216.
| Date | Jun 5, 2003 (initiated Mar 6, 2003) |
| Status | Terminated |
| Reason | A false positive result may be reported. |
| 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 | 16 |
| Distribution | Nationwide. California, Colorado, Georgia, Illinois, Maryland, Missouri, New Jersey, New Mexico, North Carolina, Utah and Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012966 | ROCHE COBAS TAQMAN ANALYZER Roche Molecular Systems, Inc., Feb 1, 2002 |