Recall Z-2082-2017— Beckman Coulter Inc.

Name: FDA recall Z-2082-2017
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: HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of 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

HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of 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.