Recall Z-0983-05 ยท MVU Reagents, Specific, Analyte
Roche Molecular Systems Inc
TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS).
| Date | Jul 13, 2005 (initiated Feb 14, 2005) |
| Status | Terminated |
| Reason | Low level of recombinant HIV DNA found in one lot of HBV QS which is a component of one lot of the TaqMan HBV ASR. |
| Root cause | Other |
| Action | Notification letter to LabCorp wa sent on 2/14/2005 via FedEx. |
| Quantity | 450 sets |
| Distribution | One customers received 14 kits on 1/3/2005. This one customer was LabCorp, 1912 Alexander Drive, Research Triangle Park, NC 27709. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.