Recall Z-2078-2017— Beckman Coulter Inc.

Name: FDA recall Z-2078-2017
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: Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF).. 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

Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration in human plasma and cerebrospinal fluid (CSF).

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.