Medical device recalls Moderate risk

bioMerieux, Inc. recalls bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134

Recall date
October 8, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0443-2019
FDA classification
Class II
Brand / firm
bioMerieux, Inc.
Sold / distributed
CA, FL, GA, MD, MI, MN, NC, NJ, NM, NY, OH, OR, RI, SC, TN, TX, VA, WA, and WI Austria, Australia, Belgium, Switzerland, Colombia, Germany, Spain, France, UK, India, Italy, Japan, Netherlands, Portugal, Sweden, Singapore, South Africa, Israel, Dutch Antilles, Angola, Estonia, and Bangladesh

Why it was recalled

Some eluates become colored because of remaining hemoglobin in the eluate.

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

What was recalled

bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134

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