Recall Z-0956-2007 ยท NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
Roche Diagnostics Corp.
MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001.
| Date | Jun 22, 2007 (initiated May 14, 2007) |
| Status | Terminated |
| Reason | False Positive Results: Product labeling states cross contamination is not an issue for high viral load titer samples, but the firm has determined that a potential sample contamination may not be detected at these levels and could result in false positive results being reported. |
| Root cause | Other |
| Action | Consignees were sent an Urgen Medical Device Correction letter dated 5/14/07 which instructs them to define and establish a lower detection limit, to use UNG to prevent carryover whenever possible, and to confirm low positive results through an independent experiment. A revised device correction letter dated 6/15/07 was subsequently sent to each consignee updating the reason for recall and associated risks. |
| Quantity | 4,201 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.