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U.S. Department of Health and Human Services

Class 2 Device Recall APhL HRP IgM ELISA Kit

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  Class 2 Device Recall APhL HRP IgM ELISA Kit see related information
Date Initiated by Firm October 06, 2005
Date Posted August 17, 2007
Recall Status1 Terminated 3 on October 11, 2007
Recall Number Z-1177-2007
Recall Event ID 38396
510(K)Number K933588  
Product Classification ELISA Kit - Product Code MID
Product APhL¿ HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360-- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. --(current 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		 Mislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.
FDA Determined
Cause 2		 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 18 IgM test kits.
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 and Original Applicant = LOUISVILLE APL DIAGNOSTICS, INC.
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