Date Initiated by Firm |
August 10, 2004 |
Date Posted |
July 24, 2007 |
Recall Status1 |
Terminated 3 on November 27, 2007 |
Recall Number |
Z-1104-2007 |
Recall Event ID |
38313 |
510(K)Number |
K933588
|
Product Classification |
in vitro diagnostic - Product Code MID
|
Product |
american diagnostica inc. IgG Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE¿ aPL IgG ELISA Kit, Product #649G; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77586. |
Code Information |
Lot #040414. |
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 |
45 |
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.
|