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Terminated

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.

FDA Recall Z-0711-2011 · Posted 2010-12-16

Recalling FirmDiagnostic Chemicals, Ltd.
Recall StatusTerminated
Product CodeCHH
Date Initiated2010-11-10
Date Terminated2011-09-19
Product Quantity30 kits

Reason for Recall

Cholesterol Reagent bottles labels reversed for R1 and R2

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide distribution: USA including states of: KY, PA, NV, and WA and country of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K842160CHOLESTEROL ASSSAY KITDiagnostic Chemicals, Ltd. (Usa) · 1984-08-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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