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.
|