🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: February 21, 2023 Entopsis Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Entopsis , Inc.
Reason for Recall:
Presence of misleading label statements on the product label.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1298-2023

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