The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1295-2023·Announced 2023-04-05

PCRopsis BCSNano nucleic acid extraction kit recalled for misleading label statements

Entopsis, Inc. is recalling PCRopsis BCSNano nucleic acid extraction kits due to misleading statements on the product label. The affected lot (Lot 3, expiring 11/2023) was 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 misleading label statements with no reported illnesses or injuries. Minor labeling errors without evidence of health harm are classified as Moderate severity per the FDA severity rubric.

Plain-English summary

PCRopsis BCSNano (1mL) is a nucleic acid extraction kit manufactured by Entopsis, Inc., designated REF 2276001. The recalled lot (Lot number 3, expiring 11/2023) was distributed nationwide and internationally to Canada, UK, Portugal, Spain, Germany, Brazil, Denmark, South Korea, Colombia, and Lithuania.

The product is being recalled due to misleading label statements on the product packaging. Users should not rely on the current product label and should contact Entopsis, Inc. for accurate labeling information before continuing to use this product.

The recalled product

Product
PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples
Manufacturer
Entopsis , Inc.
Category
Medical Device — Nucleic acid extraction
Hazard
Affected units
3

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 3
  • Exp. 11/2023

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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