Class 3 Device Recall APhL HRP IgG & IgM ELISA Kit

• Date Initiated by Firm: July 18, 2006
• Date Posted: October 04, 2007
• Recall Status: Terminated on October 24, 2007
• Recall Number: Z-0034-2008
• Recall Event ID: 39412
• 510(K)Number: K933588
• Product Classification: in vitro diagnostic - Product Code MID
• 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).
• Code Information: Lot #060425. Lot number on the outer packaging of the received kits was 060308.
• Recalling Firm/ Manufacturer: Louisville Apl Diagnostics Inc; 2622 Nasa Pkwy Ste G2; Seabrook TX 77586-3447
• For Additional Information Contact: 770-455-7129
• Manufacturer Reason for Recall: Product mislabeled; outer container labeled with incorrect lot number.
• FDA Determined 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 in Commerce: 3 test kits (each kit containing 1 IgG and 1 IgM test kit)
• Distribution: Product was shipped to a distributor in Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MID