Entopsis , Inc. recalls PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRo…

Recall date

February 21, 2023

Source

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

Recall number

Z-1301-2023

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 Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select applications; nucleic acid extraction from a variety of biological samples