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.
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 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.
- 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 (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.
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