Entopsis , Inc.: Medical Device Recall in 2023 - (Recall #: Z-1300-2023)

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 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

Product Classification:

Class II

Date Initiated: February 21, 2023

Date Posted: April 5, 2023

Recall Number: Z-1300-2023

Event ID: 91723

Reason for Recall:

Presence of misleading label statements on the product label.

Status: Ongoing

Product Quantity: 97 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated