Date Initiated by Firm |
September 06, 2006 |
Date Posted |
February 27, 2007 |
Recall Status1 |
Terminated 3 on May 14, 2007 |
Recall Number |
Z-0536-2007 |
Recall Event ID |
36864 |
510(K)Number |
K042243
|
Product Classification |
in vitro diagnostic - Product Code JIX
|
Product |
Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252 |
Code Information |
Lot Number: 28423 |
Recalling Firm/ Manufacturer |
Diagnostic Chemicals, Ltd. 16 McCarville Street Charlottetown Canada Prince Edward Island
|
For Additional Information Contact |
Karen McIntyre 293-881-2020
|
Manufacturer Reason for Recall |
Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct
|
FDA Determined Cause 2 |
Other |
Action |
Diagnostic Chemicals Ltd, Canada notified customers by telephone and fax on 9/06/06 and advised to use the cap label to determine concentration of the calibrators. Accounts were asked to confirm and acknowledge receipt of the letter. |
Quantity in Commerce |
38 kits |
Distribution |
Nationwide. |
Total Product Life Cycle |
TPLC Device Report
|
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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 = JIX and Original Applicant = DIAGNOSTIC CHEMICALS LTD.
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