The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1299-2023·Announced 2023-04-05

PCR Reagent Recalled for Misleading Label Statements

Entopsis, Inc. is recalling 397 units of PCRopsis Reagent RVD with RVD Enhancer due to misleading label statements. The affected products were distributed nationwide and internationally.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for labeling errors with no reported illnesses, injuries, or deaths. Per the rubric, minor labeling errors and voluntary precautionary recalls are classified as score 2 (Moderate).

Plain-English summary

Entopsis, Inc. is recalling 397 units of PCRopsis Reagent RVD with RVD Enhancer, a PCR reagent used for extraction-free nucleic acid detection from saliva, urine, swab specimens in transport medium, and other biological samples. The recall affects three package sizes: 1 mL (validation use only, REF 78336001), 25 mL (REF 78336025), and 100 mL (REF 78336100).

The product label contains misleading statements. The FDA recall notice does not specify the nature of these misstatements.

The recalled products were distributed nationwide and to international markets including Canada, United Kingdom, Portugal, Spain, Germany, Brazil, Denmark, South Korea, Colombia, and Lithuania. Specific lot numbers are affected with expiration dates in May and July 2023: Lots 18, 20, and 21 for the 1 mL and 25 mL sizes, and Lot 21 for the 100 mL size.

Holders of the affected products should contact Entopsis, Inc. for guidance on corrected labeling and product replacement or return options.

The recalled product

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
Entopsis , Inc.
Category
Medical Device — Diagnostic Reagent
Hazard
Affected units
397

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • a) REF 78336001
  • Lot Numbers: 18
  • Exp. 05/2023
  • 20
  • Exp. 07/2023
  • 21
  • b) REF 78336025
  • c) REF 78336100
  • Lot Numbers: 21

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Entopsis , Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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