Z-0711-2011

Genzyme Diagnostics Total Serum Cholesterol Kit, IVD Catalog Number: 225-26

Name: Z-0711-2011 Genzyme Diagnostics Total Serum Cholesterol Kit, IVD Catalog Number: 225-26
Creator: Diagnostic Chemicals, Ltd.
Published: 2010-11-10
License: https://open.fda.gov/license/

Sekisui Diagnostics P.E.I. Inc. / initiated 2010-11-10 / Terminated / root cause: labeling and UDI

FDA source

Diagnostic Chemicals, Ltd. began a recall of Genzyme Diagnostics Total Serum Cholesterol Kit, IVD Catalog Number: 225-26 Intended use: For the IN VITRO quantitative measurement of total serum cholesterol... on 2010-11-10. The reason FDA records is "Cholesterol Reagent bottles labels reversed for R1 and R2". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0711-2011
Status: Terminated
Initiated: 2010-11-10
Posted: 2010-12-16
Terminated: 2011-09-19
Recalling firm: Sekisui Diagnostics P.E.I. Inc.
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.
Product code: CHH Enzymatic Esterase--Oxidase, Cholesterol
Reason for recall: Cholesterol Reagent bottles labels reversed for R1 and R2
Root cause tag: labeling and UDI
FDA 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 in commerce: 30 kits
Distribution: Worldwide distribution: USA including states of: KY, PA, NV, and WA and country of Canada.
Product codes and lots: Lot 37772 Exp. Date: May 2011

Product code CHH

K842160Class ICholesterol Asssay KitDiagnostic Chemicals, Ltd. (Usa) / cleared 1984-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)