Medical device recalls Moderate risk

Beckman Coulter Inc. recalls Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantitative determination of Lactate concentration…

Recall date
April 3, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2078-2017
FDA classification
Class II
Brand / firm
Beckman Coulter Inc.
Sold / distributed
Worldwide Distribution -- Australia, Bangladesh, Belgium, Brunei, Bulgaria, Canada, China, Colombia, Czech Republic, Egypt, Eritrea, Finland, France, Germany, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Macau, Malaysia, Mayotte, Mexico, Net…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

Get recall alerts

Free email alert whenever Beckman Coulter Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Beckman Coulter Inc.