Recall Z-0520-2024— Meridian Bioscience Inc

Name: FDA recall Z-0520-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-19

Class II · Ongoing

Class II FDA medical device recall by Meridian Bioscience Inc, initiated 2023-10-19. It names one FDA 510(k) clearance: K792705. Product: 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..

Recalling firm: Meridian Bioscience Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-10-19
Firm location: Cincinnati, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K792705 — PARA-PAK FORMALINMeridian Diagnostics, Inc.·cleared 1980-01-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.