BioMerieux SA recalls NucliSENS Lysis Buffer Extended lot for RES 76675

Recall date

October 18, 2017

Source

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

Recall number

Z-0086-2018

FDA classification

Class II

Brand / firm

BioMerieux SA

Sold / distributed

Distributed domestically to MD, CO, and OH.

Why it was recalled

Elute may become colored due to the residual presence of heme group origination from hemoglobin present in whole blood samples as well as dried spot (DBS) samples. This can potentially cause the inhibition of PCR reactions and result in an uninterpretable test result. If using an Internal Control (IC) in the extraction process the IC could potentially be inhibited as well and invalidate test 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

NucliSENS Lysis Buffer Extended lot for RES 76675