The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1301-2023·Announced 2023-04-05

PCRopsis Support Medical Device Recall Due to Misleading Label Statements

Entopsis, Inc. is recalling PCRopsis Support nucleic acid extraction reagents due to misleading statements on product labels. No illnesses or injuries have been reported.

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 classified as FDA Class II with no reported illnesses, injuries, or deaths. The hazard involves misleading label statements, representing a labeling issue rather than a direct product defect.

Plain-English summary

Entopsis, Inc. is recalling PCRopsis Support, a medical device used for nucleic acid extraction from biological samples in laboratory and research applications. The product is available in three formulations: 1 mL (REF 787001), 0.25 mL (REF 787002), and 25 µL (REF 787003).

The recall was issued due to the presence of misleading label statements on the product packaging. A total of 94 units were affected by this recall.

The recalled product was distributed nationwide and to international locations including Canada, UK, Portugal, Spain, Germany, Brazil, Denmark, South Korea, Colombia, and Lithuania. Specific lot numbers and expiration dates are detailed in the recall notice.

The recalled product

Product
PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select applications; nucleic acid extraction from a variety of biological samples
Manufacturer
Entopsis , Inc.
Category
Medical Device — Laboratory / Diagnostics
Hazard
Affected units
94

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 (8)

  • a) REF 787001
  • Lot Numbers: 4
  • Exp. 05/2023
  • b) REF 787002
  • 5
  • Exp. 07/2023
  • c) REF 787003
  • Lot Numbers: 5 Exp. 07/2023

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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