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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 Limitedsee related information
Date Initiated by FirmDecember 05, 2006
Date PostedJanuary 23, 2007
Recall Status1 Terminated 3 on January 27, 2016
Recall NumberZ-0361-2007
Recall Event ID 37011
510(K)NumberK042329 
Product Classification in vitro diagnostic - Product Code DKJ
ProductSalicylate-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 ContactKaren 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
ActionFor 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 Commerce55 kits shipped to one customer
DistributionPA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DKJ
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