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U.S. Department of Health and Human Services

Class 2 Device Recall Diagnostic Chemicals Limited

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  Class 2 Device Recall Diagnostic Chemicals Limited see related information
Date Initiated by Firm February 12, 2009
Date Posted September 30, 2009
Recall Status1 Terminated 3 on May 23, 2012
Recall Number Z-2326-2009
Recall Event ID 51156
510(K)Number K070383  
Product Classification Enzymatic method, creatinine - Product Code JFY
Product DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number: 265-30.

In-vitro diagnostic device used for the quantitative measurement of creatine in serum, plasma and urine.
Code Information Lot Numbers:  31895 Exp. March 09, 32120 Exp March 09, 32689 Exp Marh 09 and 32383 Exp May 09.
Recalling Firm/
Manufacturer		 Diagnostic Chemicals, Ltd.
16 McCarville Street
Charlottetown Canada Prince Edward Island
Manufacturer Reason
for Recall		 Labeled with extended expiration date (24 months instead of 18 months)
FDA Determined
Cause 2		 Labeling Change Control
Action Genzyme Corp. notified consignees by Letter dated February 12, 2009 via Federal Express. Accounts are requested to discontinue use and discard units. Customers were also asked to complete and sign the Confirmation of Notification the fax to 1-902-628-6504. For further information, contact Genzyme Technical Support at 1-800-565-0265.
Quantity in Commerce 82 kits
Distribution Worldwide Distribution -- United States (AL, CA, NJ, MO, PA, KY, FL, LA, MN, NY, NC, OH, TX and UT), Canada and Korea.
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 = JFY and Original Applicant = DIAGNOSTIC CHEMICALS LTD.
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