| Date Initiated by Firm | February 14, 2005 |
|---|
| Date Posted | July 13, 2005 |
|---|
| Recall Status1 |
Terminated 3 on October 03, 2006 |
| Recall Number | Z-0983-05 |
|---|
| Recall Event ID |
31161 |
| Product Classification |
Reagents, Specific, Analyte - Product Code MVU
|
| Product | TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS). |
|---|
| Code Information |
TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, Lot F10185; HBV Quantitation Standard (HBV QS) Lot F10513. |
| FEI Number |
2243471
|
Recalling Firm/
Manufacturer |
Roche Molecular Systems Inc
1080 Us Highway 202 S
Somerville NJ 08876-3733
|
| For Additional Information Contact | Karen Z. McCullough
908-253-7610 |
|---|
Manufacturer 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. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Notification letter to LabCorp wa sent on 2/14/2005 via FedEx. |
|---|
| Quantity in Commerce | 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. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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