american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgM ELISA Kit, P
FDA device recall Z-1103-2007 · posted 2007-07-24 · Terminated
Recall details
- Recalling firm
- Louisville Apl Diagnostics Inc
- Reason for recall
- Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.
- Action taken
- Firm notified consignee of recall via phone on 08/10/04. Consignee asked to return conjugates for properly labeled replacements.
- Root cause
- Other
- Status
- Terminated
- Product code
- MID
- Quantity affected
- 35 IgM kits.
- Distribution
- Product distributed to a single direct account in CT.
- Date initiated
- 2004-08-10
- Date posted
- 2007-07-24
- Date terminated
- 2007-11-27
- Location
- Seabrook, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APHLELISA KIT (K933588) | Louisville Apl Diagnostics, Inc. | 1994-10-13 |