FDADecember 7, 2023device
Terragene Bionova PCD (PCD222-C)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
What to do
FDA enforcement status: Ongoing
Brands named
terragene
UPCs
07798164676027
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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