BioMerieux SA recalls NucliSENS Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid f…

Recall date

March 7, 2017

Source

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

Recall number

Z-1713-2017

FDA classification

Class II

Brand / firm

BioMerieux SA

Sold / distributed

Worldwide Distribution - US including IL, OH, WA, and Internationally to Argentina, Australia, Brazil, Chile, Columbia, France, Hong Kong, Italy, Netherlands, Peru, Spain, Uganda, United Kingdom, and Zimbabwe.

Why it was recalled

Problem with colored eluates for whole blood extractions

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 Lysis Buffer, REF 200292 NucliSENS Lysis Buffer is intended to be use for the release of total nucleic acid from biological specimens