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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 Recall
Diagnostic Chemicals Limited
see related information
Date Posted February 27, 2007
Recall Status1 Terminated on May 14, 2007
Recall Number Z-0536-2007
Recall Event ID 36864
Premarket Notification
510(K) Number
K042243 
Product Classification Calibrator, Multi-Analyte Mixture - 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, 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
PRODUCTION CONTROLS: Packaging Process Control
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JIX and Original Applicant = DIAGNOSTIC CHEMICALS LTD.
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