Entopsis , Inc. recalls PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF

Recalled April 5, 2023 · FDA recall Z-1298-2023 · Entopsis

Hazard

Presence of misleading label statements on the product label. · FDA Class II

Units

363 units

Sold at

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

Description

Presence of misleading label statements on the product label.

Product

PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples

Manufacturer(s)

Entopsis , Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →