FDA recall Z-0837-2024

TERRAGENE S.A. · Class II · device

Product

Terragene Bionova PCD (PCD222-C)

Reason for recall

Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.

Distribution

U.S. Nationwide distribution in the states of GA, IN, MI, MT, NY, PA, TX and VA.

Key facts

Status
Ongoing
Initiation date
2023-12-07
Report date
2024-02-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Alvear, Argentina

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0837-2024