Home / Recalls / Medical Devices
Entopsis , Inc. recalls PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL,
Recalled April 5, 2023 · FDA recall Z-1299-2023 · Entopsis
Hazard
Presence of misleading label statements on the product label. · FDA Class II
Units
397 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 Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, 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 →