The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1297-2023·Announced 2023-04-05

PCRopsis Activator nucleic acid extraction kits recalled for misleading labels

Entopsis, Inc. is recalling PCRopsis Activator nucleic acid extraction kits due to misleading label statements. The 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 a Class II recall with no reported illnesses or injuries. The hazard is purely labeling-related (misleading label statements) rather than a physical or biological product defect, consistent with the rubric criterion of minor labeling errors.

Plain-English summary

Entopsis, Inc. is recalling PCRopsis Activator nucleic acid extraction kits in two sizes (1.5mL and 0.5mL) due to misleading statements on the product label. The U.S. Food and Drug Administration issued this Class II recall.

The affected products were distributed to customers nationwide and across multiple countries, including Canada, the United Kingdom, Portugal, Spain, Germany, Brazil, Denmark, South Korea, Colombia, and Lithuania. The recall affects 52 units total.

While the FDA classified this as a Class II recall based on labeling concerns, the specific content of the misleading statements is not detailed in the available recall information.

The recalled product

Product
PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples
Manufacturer
Entopsis , Inc.
Category
Medical Device — Diagnostic Reagent
Hazard
Affected units
52

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 (7)

  • a) REF 282001: Lot Numbers: 3
  • Exp. 05/2023
  • 4
  • Exp. 07/2023
  • b) REF 228002: Lot Numbers: 3
  • 5
  • Exp. 04/2023

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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