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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 December 05, 2006
Date Posted January 23, 2007
Recall Status1 Terminated 3 on January 27, 2016
Recall Number Z-0361-2007
Recall Event ID 37011
510(K)Number K042329  
Product Classification in vitro diagnostic - Product Code DKJ
Product Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892
Code Information Lot 29892
Recalling Firm/
Manufacturer		 Diagnostic Chemicals, Ltd.
16 McCarville Street
Charlottetown Canada Prince Edward Island
For Additional Information Contact Karen MacIntyre
800-325 Ext. 2436
Manufacturer Reason
for Recall		 Upon subsequent testing on different instruments (as required by other customers), DCL detected a non-linear response on certain analyzers. A decision was made to recall the product due to the fact that DCL customers sell the product to different end users, DCL cannot be certain which instruments the end users employ in their laboratories
FDA Determined
Cause 2		 Other
Action For product shipped by DCL to one customer notification letter dated 12/5/06 sent out to customer to return/discard product. Replacement will be sent to customer. For product shipped to DCL (USA) warehouse notification sent to discard kits remaining in stock. For product remaining at DCL Canada in-house notification sent out to discard in-house kits.
Quantity in Commerce 55 kits shipped to one customer
Distribution PA
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 = DKJ and Original Applicant = DIAGNOSTIC CHEMICALS LTD.
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