FDAFDA · Food and drugs·Recall number Z-1299-2023
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
Published April 5, 2023 · Recall initiated: February 21, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of misleading label statements on the product label.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Entopsis , Inc.
- Distributor
- Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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