TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS).
FDA device recall Z-0983-05 · posted 2005-07-13 · Terminated
Recall details
- Recalling firm
- Roche Molecular Systems Inc
- Reason for recall
- 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.
- Action taken
- Notification letter to LabCorp wa sent on 2/14/2005 via FedEx.
- Root cause
- Other
- Status
- Terminated
- Product code
- MVU
- Quantity affected
- 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.
- Date initiated
- 2005-02-14
- Date posted
- 2005-07-13
- Date terminated
- 2006-10-03
- Location
- Somerville, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.