FDA recall Z-0521-2024

Meridian Bioscience Inc · Class II · device

Product

Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312

Reason for recall

Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.

Distribution

Nationwide Foreign: Italy

Key facts

Status
Ongoing
Initiation date
2023-10-19
Report date
2023-12-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cincinnati, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0521-2024