The Recall Desk
ModerateFDA (Devices)·Z-1296-2023·Announced 2023-04-05

PCRopsis Reagent Buccal Kit Recalled for Misleading Label Statements

Entopsis, Inc. is recalling PCRopsis Reagent Buccal (REF 282001), an extraction-free PCR reagent kit, due to misleading label statements on the product labeling.

What this means for you

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 FDA Class II recall is due to misleading label statements on medical device labeling. The issue is classified as a labeling error without reported contamination or product defect, aligning with severity 2 (Moderate) per the rubric.

Plain-English summary

PCRopsis Reagent Buccal (IVD, REF 282001) is an extraction-free PCR reagent kit manufactured by Entopsis, Inc. The product is used for nucleic acid extraction from buccal swabs and other biological samples, supplied in packages of 6 units.

The product is being recalled due to the presence of misleading label statements on the product labeling. The FDA has classified this as a Class II recall.

Affected units include Lot number 4 with an expiration date of August 2023. The product was distributed nationwide and internationally, including Canada, the United Kingdom, Portugal, Spain, Germany, Brazil, Denmark, South Korea, Colombia, and Lithuania.

The recalled product

Product
PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples
Manufacturer
Entopsis , Inc.
Category
Medical Device — Nucleic Acid Extraction / PCR Reagent
Hazard
Affected units
6

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 (2)

  • Lot number 4
  • Exp. 08/2023

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 →

Related recalls

Same manufacturer · Entopsis , Inc.

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