Genzyme Diagnostics Total Serum Cholesterol Kit, IVD Catalog Number: 225-26 Intended use: For the IN VITRO quantitative
FDA device recall Z-0711-2011 · posted 2010-12-16 · Terminated
Recall details
- Recalling firm
- Diagnostic Chemicals, Ltd.
- Reason for recall
- Cholesterol Reagent bottles labels reversed for R1 and R2
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- CHH
- Quantity affected
- 30 kits
- Distribution
- Worldwide distribution: USA including states of: KY, PA, NV, and WA and country of Canada.
- Date initiated
- 2010-11-10
- Date posted
- 2010-12-16
- Date terminated
- 2011-09-19
- Location
- Charlottetown, Canada
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHOLESTEROL ASSSAY KIT (K842160) | Diagnostic Chemicals, Ltd. (Usa) | 1984-08-17 |