VIDAS Lyme IgG and IgM LYT, Ref #30 298, containing 60 LYT STR (reagent strip labels), 2 x 30 LYT SPR (Solid Phase Recep
FDA device recall Z-0316-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Biomerieux, Inc.
- Reason for recall
- Kit may contain incorrect components
- Action taken
- Recall letters dated 10/28/03 were issued via regular mail instructing the customer to examine the kits to determine whether they contain the CMV IgG SPRS and destroy them if found.
- Root cause
- Other
- Status
- Terminated
- Product code
- LSR
- Quantity affected
- 329 kits
- Distribution
- Distribution was made nationwide to hospitals and laboratories.
- Date initiated
- 2003-10-28
- Date posted
- 2004-07-20
- Date terminated
- 2004-08-13
- 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 LYME SCREEN II (K943812) | Biomerieux Vitek, Inc. | 1995-06-13 |