Entopsis , Inc. recalls PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free P…

Recall date

February 21, 2023

Source

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

Recall number

Z-1300-2023

FDA classification

Class II

Brand / firm

Entopsis , Inc.

Sold / distributed

Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania

Why it was recalled

Presence of misleading label statements on the product label.

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

What was recalled

PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological samples