american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgM ELISA Kit, Product #649M; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77586.
This recall has been terminated (originally issued July 24, 2007).
- Company
- Louisville Apl Diagnostics Inc
- Recall Initiated
- August 10, 2004
- Posted
- July 24, 2007
- Terminated
- November 27, 2007
- Recall Number
- Z-1103-2007
- Quantity
- 35 IgM kits.
- Firm Location
- Seabrook, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.
Distribution
Product distributed to a single direct account in CT.
Lot / Code Info
Lot #040531.
Root Cause
Other
Action Taken
Firm notified consignee of recall via phone on 08/10/04. Consignee asked to return conjugates for properly labeled replacements.
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