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U.S. Department of Health and Human Services

Class 3 Device Recall Diagnostic Chemicals Limited

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  Class 3 Device Recall Diagnostic Chemicals Limited see related information
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/
Diagnostic Chemicals, Ltd.
16 McCarville Street
Charlottetown Canada Prince Edward Island
For Additional Information Contact Karen McIntyre
Manufacturer Reason
for Recall
Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct
FDA Determined
Cause 2
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

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.