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U.S. Department of Health and Human Services

Class 2 Device Recall IgM ELISA Kit

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  Class 2 Device Recall IgM ELISA Kit see related information
Date Initiated by Firm August 10, 2004
Date Posted July 24, 2007
Recall Status1 Terminated 3 on November 27, 2007
Recall Number Z-1103-2007
Recall Event ID 38313
510(K)Number K933588  
Product Classification in vitro diagnostic - Product Code MID
Product 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.
Code Information Lot #040531.
Recalling Firm/
Manufacturer		 Louisville Apl Diagnostics Inc
2622 NASA Parkway, Suite G2
Seabrook TX 77586-3447
For Additional Information Contact
770-455-7129
Manufacturer Reason
for Recall		 Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.
FDA Determined
Cause 2		 Other
Action Firm notified consignee of recall via phone on 08/10/04. Consignee asked to return conjugates for properly labeled replacements.
Quantity in Commerce 35 IgM kits.
Distribution Product distributed to a single direct account in CT.
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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