FDA-Device2023-12-20Class II

Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012

Meridian Bioscience Inc
Hazard

Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen.

Sold states
Nationwide Foreign: Italy
Affected count
201 Cases
Manufactured in
3471 River Hills Dr, N/A, Cincinnati, OH, United States
Products
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0520-2024

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