Recall Z-0774-06 ยท NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
Roche Diagnostics Corp.
Roche MagNA Pure LC System. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions. Catalog numbers 12236931001 and 03670325001
| 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 | 251 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.