Recall Z-0711-2011 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
Diagnostic Chemicals, Ltd.
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.
| Date | Dec 16, 2010 (initiated Nov 10, 2010) |
| Status | Terminated |
| Reason | Cholesterol Reagent bottles labels reversed for R1 and R2 |
| Root cause | 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 | 30 kits |
| Distribution | Worldwide distribution: USA including states of: KY, PA, NV, and WA and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842160 | CHOLESTEROL ASSSAY KIT Diagnostic Chemicals, Ltd. (Usa), Aug 17, 1984 |