Recall Z-1119-04 ยท JJF Analyzer, Chemistry, Micro, For Clinical Use
Roche Molecular Systems Inc
COBAS TaqMan Analyzer
| Date | Jul 27, 2004 (initiated May 24, 2004) |
| Status | Terminated |
| Reason | 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. |
| 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 | 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. |
| 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 |