APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc
FDA device recall Z-0034-2008 · posted 2007-10-04 · Terminated
Recall details
- Recalling firm
- Louisville Apl Diagnostics Inc
- Reason for recall
- Product mislabeled; outer container labeled with incorrect lot number.
- Action taken
- Firm sent replacement labels to consignee via FedEx on 07/18/06 with instructions for consignee to change the labels on the kit boxes before shipping kits to end users.
- Root cause
- Process design
- Status
- Terminated
- Product code
- MID
- Quantity affected
- 3 test kits (each kit containing 1 IgG and 1 IgM test kit)
- Distribution
- Product was shipped to a distributor in Canada.
- Date initiated
- 2006-07-18
- Date posted
- 2007-10-04
- Date terminated
- 2007-10-24
- 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 |