Recall Z-0297-05 ยท NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
Roche Diagnostics Corp.
MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.
| Date | Dec 8, 2004 (initiated Nov 5, 2004) |
| Status | Terminated |
| Reason | Test results may be adversely affected by software shutting down the cooling blocks in systems with software version 3.09. |
| Root cause | Other |
| Action | Consignees were notified via letter dated 11/5/04, which provides the user with a workaround. |
| Quantity | 65 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.