Recall Z-0711-2011
Diagnostic Chemicals, Ltd. · initiated November 10, 2010
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.
Codes / lots: Lot 37772 Exp. Date: May 2011
Reason for recall
Cholesterol Reagent bottles labels reversed for R1 and R2
FDA-determined cause: Labeling mix-ups
Action taken
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.
Details
- Recall number
- Z-0711-2011
- Initiated
- November 10, 2010
- Posted by FDA
- December 16, 2010
- Terminated
- September 19, 2011
- Product code
- CHH – Enzymatic Esterase--Oxidase, Cholesterol
- Quantity
- 30 kits
- Distribution
- Worldwide distribution: USA including states of: KY, PA, NV, and WA and country of Canada.
- Recalling firm
- Diagnostic Chemicals, Ltd., Charlottetown