Recall Z-1371-04 ยท NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
Roche Diagnostics Corp.
MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001.
| Date | Aug 17, 2004 (initiated Aug 6, 2004) |
| Status | Terminated |
| Reason | A hardware/software problem will result in low elution volumes and bias sample results for various protocols. |
| Root cause | Other |
| Action | Consignees were notified via recall letter dated 8/6/04. |
| Quantity | 192 |
| Distribution | United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.