FDA Medical Device Recalls (openFDA)
Louisville Apl Diagnostics Inc: APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).
- Recall number
- Z-0034-2008
- Recalling firm
- Louisville Apl Diagnostics Inc
- Product
- APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).
- Status
- Terminated
- Initiated
- 2006-07-18
- Posted
- 2007-10-04
- Terminated
- 2007-10-24
- Reason
- Product mislabeled; outer container labeled with incorrect lot number.
- Root cause
- Process design
- Action
- 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.
- Quantity
- 3 test kits (each kit containing 1 IgG and 1 IgM test kit)
- Distribution
- Product was shipped to a distributor in Canada.
- Lot, serial or model codes
- Lot #060425. Lot number on the outer packaging of the received kits was 060308.
- 510(k) numbers
- ["K933588"]
- PMA numbers
- not on file
- Product code
- MID
- Firm FEI
- 1000305932
- Firm city
- Seabrook
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28