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U.S. Department of Health and Human Services

Class 3 Device Recall Iron Assay

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  Class 3 Device Recall Iron Assay see related information
Date Initiated by Firm March 14, 2008
Date Posted May 13, 2009
Recall Status1 Terminated 3 on May 16, 2012
Recall Number Z-1327-2009
Recall Event ID 47475
510(K)Number K961587  
Product Classification Ferrozine Iron Binding Capacity - Product Code JMO
Product Diagnostics Chemical Limited Iron Assay
Catalog Number: 102-25

For the In Vitro quantitative determination of iron in serum.
Code Information Lot Number: 33361 Exp: October 2010
Recalling Firm/
Manufacturer		 Diagnostic Chemicals, Ltd.
16 McCarville Street
Charlottetown Canada Prince Edward Island
Manufacturer Reason
for Recall		 Precipitate in product may cause elevated background absorbance interference.
FDA Determined
Cause 2		 Process control
Action Genzyme Diagnostics P.E.I. Inc. notified the 1 account by a Removal Notification letter on 3/14/08 requesting that they stop using and discard any remaining stock. The customer is to request replacement through their normal channels. Questions or concerns should be directed to Penny White of Genzyme.
Quantity in Commerce 153 kits
Distribution Nationwide Distribution
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 = JMO and Original Applicant = DIAGNOSTIC CHEMICALS LTD.
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