Home / Recalls / Entopsis , Inc. / Z-1299-2023

Z-1299-2023 Class II Ongoing

Recalled by Entopsis , Inc. — Medley, FL

Recall Details

Product Type
Devices
Report Date
April 5, 2023
Initiation Date
February 21, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
397 units

Product Description

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

Reason for Recall

Presence of misleading label statements on the product label.

Distribution Pattern

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

Code Information

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

Other recalls by Entopsis , Inc.

  • Z-1295-2023 Class II — PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of b (February 21, 2023)
  • Z-1300-2023 Class II — PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c (February 21, 2023)
  • Z-1296-2023 Class II — PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (February 21, 2023)
  • Z-1297-2023 Class II — PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid ext (February 21, 2023)
  • Z-1301-2023 Class II — PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 7 (February 21, 2023)
  • Z-1298-2023 Class II — PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c (February 21, 2023)