BioMerieux SA recalls NucliSENS¿ Magnetic Extraction Reagents

Recall date

September 17, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0218-2019

FDA classification

Class II

Brand / firm

BioMerieux SA

Sold / distributed

Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA.

Why it was recalled

Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.

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

What was recalled

NucliSENS¿ Magnetic Extraction Reagents