FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0711-2011
- Recalling firm
- Diagnostic Chemicals, Ltd.
- 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.
- Status
- Terminated
- Initiated
- 2010-11-10
- Posted
- 2010-12-16
- Terminated
- 2011-09-19
- 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.
- Lot, serial or model codes
- Lot 37772 Exp. Date: May 2011
- 510(k) numbers
- ["K842160"]
- PMA numbers
- not on file
- Product code
- CHH
- Firm FEI
- 3002806809
- Firm city
- Charlottetown
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28