The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1300-2023·Announced 2023-04-05

PCRopsis Reagent RVD-RT in vitro diagnostic kit recall for misleading labels

Entopsis, Inc. is recalling PCRopsis Reagent RVD-RT diagnostic kits due to misleading label statements that could affect proper use and test interpretation.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The product is an in vitro diagnostic reagent; misleading label statements present a risk of harm through incorrect test results or improper usage, even though no illnesses or injuries have been reported. This meets the criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Entopsis, Inc. is recalling PCRopsis Reagent RVD-RT, an in vitro diagnostic kit used for extraction-free PCR at room temperature and nucleic acid extraction from biological samples, due to misleading label statements on the product label.

Misleading labels on diagnostic reagents could lead to improper use, incorrect interpretation of test results, or suboptimal sample handling. No illnesses or injuries have been reported.

The recall affects 97 units distributed nationwide and internationally to Canada, UK, Portugal, Spain, Germany, Brazil, Denmark, South Korea, Colombia, and Lithuania. Affected lot numbers are: REF 78378001 (1 mL, Lot 4 Exp. 02/2023 and Lot 7 Exp. 07/2023), REF 78378025 (25 mL, Lot 6 Exp. 06/2023), and REF 78378100 (100 mL, Lot 7 Exp. 07/2023).

Consumers who have purchased affected lots should stop using the product and contact Entopsis, Inc. for replacement or refund instructions.

The recalled product

Product
PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological samples
Manufacturer
Entopsis , Inc.
Category
Medical Device — Diagnostic Reagent
Hazard
Affected units
97

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 (10)

  • a) REF 78378001
  • Lot Numbers: 4
  • Exp. 02/2023
  • 7
  • Exp. 07/2023
  • b) REF 78378025
  • Lot Numbers: 6
  • Exp. 06/2023
  • c) REF 78378100
  • Lot Numbers: 7

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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