Reported Apr 5, 2023 · Ongoing
PCRopsis Reagent RVD with RVD Enhancer
Entopsis , Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Entopsis , Inc. · 7600 Nw 69th Ave · Medley, FL · 33166-2521
Is this the product you have?
PCRopsis Reagent RVD with RVD Enhancer
3 of 3 products
| Model / number | Product as published |
|---|---|
78336001 | 1 mL, VALIDATION USE ONLY |
78336025 | 25 mL |
78336100 | 100 mL, ; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples |
- Lot codes and dates
- a) REF 78336001
- Lot Numbers
18Exp. 05/202320Exp. 07/202321Exp. 07/2023b) REF 78336025
- Lot Numbers
18Exp. 05/202320Exp. 07/202321Exp. 07/2023c) REF 78336100
- Lot Numbers
21Exp. 07/2023
- Amount recalled
- 397 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
Presence of misleading label statements on the product label.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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