Recall Z-0521-2024— Meridian Bioscience Inc

Name: FDA recall Z-0521-2024
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: K792710. Product: Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312. Reason: Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage..

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

K792710 — PARA-PAK CLEAN VIALMeridian Diagnostics, Inc.·cleared 1980-01-28

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

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.

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