Class 2 Device Recall APhL HRP IgG & IgM ELISA Kit

• Date Initiated by Firm: October 06, 2005
• Date Posted: August 17, 2007
• Recall Status: Terminated on October 11, 2007
• Recall Number: Z-1175-2007
• Recall Event ID: 38396
• 510(K)Number: K933588
• Product Classification: ELISA Kit - Product Code MID
• Product: APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. (address now in Seabrook, TX 77586).
• Code Information: Lot #050723
• 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: Mislabeing : Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.
• FDA Determined Cause: Other
• Action: Firm notified consignees of recall via fax on 05/05-06/2005. Consignees asked to replace Quality Control Fact Sheets shipped with test kits with the corrected Quality Control Fact Sheets provided with fax.
• Quantity in Commerce: 29 test kits (ea. kit containing 1 IgG and 1 IgM test kit)
• Distribution: World Wide: Product distributed to direct accounts in CA, FL and GA. Foreign consignees located in Canada and Turkey.
• 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