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U.S. Department of Health and Human Services

Class 3 Device Recall Genzyme Diagnostics Total Serum Cholesterol Kit,

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 Class 3 Device Recall Genzyme Diagnostics Total Serum Cholesterol Kit,see related information
Date Initiated by FirmNovember 10, 2010
Date PostedDecember 16, 2010
Recall Status1 Terminated 3 on September 19, 2011
Recall NumberZ-0711-2011
Recall Event ID 57230
510(K)NumberK842160 
Product Classification Enzymatic esterase--oxidase, cholestrol - Product Code CHH
ProductGenzyme Diagnostics Total Serum Cholesterol Kit, IVD Catalog Number: 225-26 Intended use: For the IN VITRO quantitative measurement of total serum cholesterol in serum.
Code Information Lot 37772  Exp. Date: May 2011
FEI Number 3002806809
Recalling Firm/
Manufacturer		 Diagnostic Chemicals, Ltd.
16 McCarville Street
Charlottetown Canada
Manufacturer Reason
for Recall		Cholesterol Reagent bottles labels reversed for R1 and R2
FDA Determined
Cause 2		Labeling mix-ups
ActionGenzyme Diagnostics P.E.I. Inc. sent an "IMPORTANT PRODUCT FIELD CORRECTION" letter dated November 10, 2010, via Federal Express to customers. The letter described the label error and requested that the reagents not be interchanged with another reagent lot. The firm ask that the customers complete and return the attached IMPORTANT PRODUCT FIELD CORRECTION confirmation of notification via fax at 902-628-6504. Contact a Genzyme Diagnostics Technical Services Representative at 1-800- 565-0265, if you require further information, or if you have any questions.
Quantity in Commerce30 kits
DistributionWorldwide distribution: USA including states of: KY, PA, NV, and WA and country of Canada.
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 = CHH
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