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 Buccal 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 Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples

Quantity: 6 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