Entopsis , Inc.: Medical Device Recall in 2023 - (Recall #: Z-1298-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product 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 Classification:

Class II

Date Initiated: February 21, 2023

Date Posted: April 5, 2023

Recall Number: Z-1298-2023

Event ID: 91723

Reason for Recall:

Presence of misleading label statements on the product label.

Status: Ongoing

Product Quantity: 363 units

Code Information:

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

Distribution Pattern:

Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania

Voluntary or Mandated:

Voluntary: Firm initiated