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).
This recall has been terminated (originally issued October 4, 2007).
- Company
- Louisville Apl Diagnostics Inc
- Recall Initiated
- July 18, 2006
- Posted
- October 4, 2007
- Terminated
- October 24, 2007
- Recall Number
- Z-0034-2008
- Quantity
- 3 test kits (each kit containing 1 IgG and 1 IgM test kit)
- Firm Location
- Seabrook, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Product mislabeled; outer container labeled with incorrect lot number.
Distribution
Product was shipped to a distributor in Canada.
Lot / Code Info
Lot #060425. Lot number on the outer packaging of the received kits was 060308.
Root Cause
Process design
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.
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