Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL Recalled by Entopsis , Inc. Due to Presence of misleading label statements on the product...

Date: February 21, 2023
Company: Entopsis , Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Entopsis , Inc. directly.

Affected Products

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

Quantity: 397 units

Why Was This Recalled?

Presence of misleading label statements on the product label.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Entopsis , Inc.

Entopsis , Inc. has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report