FDA Enforcement
Class II
Ongoing
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
Recall: Z-0520-2024
·
Reported December 20, 2023
Enforcement
- Recall Number
- Z-0520-2024
- Event ID
- 93350
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Meridian Bioscience Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- December 20, 2023
- Initiation Date
- October 19, 2023
- Classification Date
- December 8, 2023
- Address
- 3471 River Hills Dr, N/A, Cincinnati, OH, 45244-3023, United States
Description
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
Reason
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.
Code Info
UDI-DI: 00840733101250 Lot Numbers: 509130Q Expiration Date: 08/11/2025
Distribution
Nationwide Foreign: Italy
Quantity
201 Cases