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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Entopsis , Inc.: Presence of misleading label statements on the product label.

Agency Publication Date: March 29, 2023
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Affected Products

Product: PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples

Lot number 3, Exp. 11/2023

Lot Numbers:
number
Product: PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples

Lot number 4, Exp. 08/2023

Lot Numbers:
number
Product: PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples

a) REF 282001: Lot Numbers: 3, Exp. 05/2023; 4, Exp. 07/2023; b) REF 228002: Lot Numbers: 3, Exp. 05/2023; 4, Exp. 07/2023; 5, Exp. 04/2023

Lot Numbers:
Numbers
Numbers
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

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, Exp. 05/2024; d) REF 5970025, Lot Numbers: 2, Exp. 05/2024; 3, Exp. 06/2024; 4, Exp. 06/2024; 5, Exp. 06/2024; e) REF 5971000, Lot Numbers: 4, Exp. 06/2024

Lot Numbers:
Numbers
Numbers
Numbers
Numbers
Numbers
Product: PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples

a) REF 78336001, Lot Numbers: 18, Exp. 05/2023; 20, Exp. 07/2023; 21, Exp. 07/2023; b) REF 78336025, Lot Numbers: 18, Exp. 05/2023; 20, Exp. 07/2023; 21, Exp. 07/2023; c) REF 78336100, Lot Numbers: 21, Exp. 07/2023

Lot Numbers:
Numbers
Numbers
Numbers
Product: PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological samples

a) REF 78378001, Lot Numbers: 4, Exp. 02/2023; 7, Exp. 07/2023; b) REF 78378025, Lot Numbers: 6, Exp. 06/2023; c) REF 78378100, Lot Numbers: 7, Exp. 07/2023

Lot Numbers:
Numbers
Numbers
Numbers
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

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

Lot Numbers:
Numbers
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Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91723
Status: Active
Manufacturer: Entopsis , Inc.
Manufactured In: United States
Units Affected: 7 products (3 units; 6 units; 52 units; 363 units; 397 units; 97 units; 94 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.