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Recall Observatory FDA recall evidence

Device product

Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312

Z-0519-2024

October 19, 2023

Class II

Product summary

Firm
Meridian Bioscience Inc
Event
Event 93350
Status
Ongoing
Classification
Class II
Quantity
571 Cases
Official record key
device-enforcement:Z-0519-2024

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: 00840733101892 Lot Numbers: 509940Q Expiration Date: 09/12/2030

Distribution pattern: Nationwide Foreign: Italy

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing defect