Recall Z-0775-06 ยท NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
Roche Diagnostics Corp.
Roche MagNA Pure LC DNA Isolation Kit - Large Volume; Catalog number 03310515001.
| Date | Apr 19, 2006 (initiated Apr 4, 2006) |
| Status | Terminated |
| Reason | The firm has received complaints of reagent splattering on the deck of the instrument and possible cross contamination of samples purified on the instrument. |
| Root cause | Other |
| Action | Consignees were notified by letter dated 4/4/06 to notify customers of the problem and provide a work-around. |
| Quantity | unknown. |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.