VIDAS CMV IgG Assay
FDA device recall Z-1047-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- bioMerieux
- Reason for recall
- The product may give false positive results.
- Action taken
- Consignees were notified by letter on June 9, 2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- LFZ
- Quantity affected
- 148 units
- Distribution
- AR, CA, FL, GA, IL, IN, KY, MA, MD, MN, MS, MT, NC, NE, NH, NJ, NY, OH, PA, RI, SD, TN, VA.
- Date initiated
- 2004-06-09
- Date posted
- 2004-07-20
- Date terminated
- 2005-01-12
- Location
- Durham, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIDAS CMV IGG ASSAY (K920661) | Vitek Systems, Inc. | 1993-02-12 |