APhL HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360-- Qu
FDA device recall Z-1177-2007 · posted 2007-08-17 · Terminated
Recall details
- Recalling firm
- Louisville Apl Diagnostics Inc
- Reason for recall
- Mislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.
- Action taken
- Firm notified consignees of recall via fax on 05/05-06/2005. Consignees asked to replace Quality Control Fact Sheets shipped with test kits with the corrected Quality Control Fact Sheets provided with fax.
- Root cause
- Other
- Status
- Terminated
- Product code
- MID
- Quantity affected
- 18 IgM test kits.
- Distribution
- World Wide: Product distributed to direct accounts in CA, FL and GA. Foreign consignees located in Canada and Turkey.
- Date initiated
- 2005-10-06
- Date posted
- 2007-08-17
- Date terminated
- 2007-10-11
- 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 |