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Recall Observatory FDA recall evidence

Device product

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

Z-0520-2024

October 19, 2023

Class II

Product summary

Firm
Meridian Bioscience Inc
Event
Event 93350
Status
Ongoing
Classification
Class II
Quantity
201 Cases
Official record key
device-enforcement:Z-0520-2024

Official wording

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 information: UDI-DI: 00840733101250 Lot Numbers: 509130Q Expiration Date: 08/11/2025

Distribution pattern: Nationwide Foreign: Italy

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing defect