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.
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 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.
- Hazard
- mis-labeling
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.
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