Reported Apr 5, 2023 · Ongoing
PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free…
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-RT
- IVDa) 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
- Lot codes and dates
- a) REF 78378001
- Lot Numbers
4Exp. 02/20237Exp. 07/2023b) REF 78378025
- Lot Numbers
6Exp. 06/2023c) REF 78378100
- Lot Numbers
7Exp. 07/2023
- Amount recalled
- 97 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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