Recall Z-2081-2017— Beckman Coulter Inc.

Name: FDA recall Z-2081-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-03

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2017-04-03, terminated 2018-05-31. FDA's recall record names no specific 510(k) clearance for this event. Product: Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasma.. Reason: Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-04-03
Terminated: 2018-05-31
Firm location: Brea, CA, United States

Product description

Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantitative determination of cholesterol concentration in human serum or plasma.

Reason for recall

Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.

Data sourced from openFDA. This site is unofficial and independent of the FDA.