Date Initiated by Firm |
November 10, 2010 |
Date Posted |
December 16, 2010 |
Recall Status1 |
Terminated 3 on September 19, 2011 |
Recall Number |
Z-0711-2011 |
Recall Event ID |
57230 |
510(K)Number |
K842160
|
Product Classification |
Enzymatic esterase--oxidase, cholestrol - Product Code CHH
|
Product |
Genzyme 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 |
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 |
Action |
Genzyme 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 Commerce |
30 kits |
Distribution |
Worldwide distribution: USA including states of: KY, PA, NV, and WA and country of Canada. |
Total Product Life Cycle |
TPLC Device Report
|
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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 = CHH and Original Applicant = DIAGNOSTIC CHEMICALS, LTD. (USA)
|