Medical device lysis beads recalled for misleading label statements
Entopsis recalls PCRopsis Lysis Beads (363 units) due to misleading label statements on the product packaging. The affected product was distributed nationwide and to Canada, UK, Portugal, Spain, Germany, Brazil, Denmark, South Korea, Colombia, and Lithuania.
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 an FDA Class II recall for a labeling defect with no reported illnesses or injuries. The issue constitutes a minor labeling error, which per the severity rubric warrants a Moderate rating.
Plain-English summary
Entopsis, Inc. is recalling PCRopsis Lysis Beads, a medical device used for nucleic acid extraction from biological samples in laboratory settings. The recall affects 363 units in multiple package configurations with reference numbers 597000, 597825, 597850, 5970025, and 5971000.
The FDA classified this as a Class II recall due to the presence of misleading label statements on the product label.
The affected product was distributed nationwide and internationally to Canada, UK, Portugal, Spain, Germany, Brazil, Denmark, South Korea, Colombia, and Lithuania. Customers who have received this product should review their labels and consult the manufacturer or FDA for guidance.
The recalled product
- Product
- PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples
- Manufacturer
- Entopsis , Inc.
- Hazard
- misleading-labels
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 (15)
- a) REF 597000
- Lot Numbers: 2
- Exp. 05/2024
- 3
- Exp. 6024
- b) REF 597825
- Lot Numbers: 5
- Exp. 06/2024
- c) REF 597850
- Lot Numbers: 2
- d) REF 5970025
- 4
- 5
- e) REF 5971000
- Lot Numbers: 4
Distribution
Distributed nationwide across the United States.
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