Date Initiated by Firm |
January 08, 2003 |
Date Posted |
May 29, 2003 |
Recall Status1 |
Terminated 3 on September 13, 2008 |
Recall Number |
Z-0898-03 |
Recall Event ID |
26138 |
510(K)Number |
K950803
|
Product Classification |
Enzyme Controls (Assayed And Unassayed) - Product Code JJT
|
Product |
Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100. |
Code Information |
Lot #115496, Exp. 11/1/03 |
Recalling Firm/ Manufacturer |
PerkinElmer LIfe Sciences Inc 3985 Eastern Rd Norton OH 44203
|
Manufacturer Reason for Recall |
The Control Cards are incorrectly labeled such that the normal 'N' and abnormal 'A' values are reversed.
|
FDA Determined Cause 2 |
Other |
Action |
The firm notified their customers by letter on 1/8/2003. |
Quantity in Commerce |
75 Kits |
Distribution |
The kits were shipped to three (3) State Departments of Health in WI, AR, and MI. |
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 = JJT and Original Applicant = ISOLAB, INC.
|