Reported Feb 7, 2024 · Ongoing
Terragene Bionova PCD (PCD222-C)
Terragene S.a.
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: TERRAGENE S.A. · Ruta Nacional N 9, Km 280, Cp 2130 · Alvear · N/A
Is this the product you have?
- Terragene Bionova PCD (PCD222-C)
- Lot codes and dates
- Product NumberTerragene
- Bionova PCD (PCD222-C) UDI-DI code07798164676027
- Serial NumbersF20002 F20021 F20046
- Amount recalled
- 80 stripes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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