FDA Medical Device Recalls (openFDA)
Louisville Apl Diagnostics Inc: american diagnostica inc. IgG Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgG ELISA Kit, Product #649G; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77586.
- Recall number
- Z-1104-2007
- Recalling firm
- Louisville Apl Diagnostics Inc
- Product
- american diagnostica inc. IgG Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgG ELISA Kit, Product #649G; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77586.
- Status
- Terminated
- Initiated
- 2004-08-10
- Posted
- 2007-07-24
- Terminated
- 2007-11-27
- Reason
- Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.
- Root cause
- Other
- Action
- Firm notified consignee of recall via phone on 08/10/04. Consignee asked to return conjugates for properly labeled replacements.
- Quantity
- 45
- Distribution
- Product distributed to a single direct account in CT.
- Lot, serial or model codes
- Lot #040414.
- 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