Agency classClass IIOur severity:High FDA (Devices)·Z-0519-2024·Announced 2023-12-20

Para-Pak Clean Vial Stool Collection Kits Recalled for Manufacturing Defect

Meridian Bioscience is recalling Para-Pak Clean Vials used for stool specimen collection due to a manufacturing defect that increases leakage risk and may expose users to biological hazards.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device with a manufacturing defect that presents a theoretical risk of biological exposure to patient specimens. No illnesses or injuries have been reported. Per the severity rubric, this constitutes a risk-of-harm product where injury has not yet been reported, warranting a score of 3 (High).

Plain-English summary

Meridian Bioscience Inc. is recalling Para-Pak Clean Vials (Catalog Number 900312), which are used for the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites. The recall affects 571 cases distributed nationwide and internationally (Italy).

The plastic vials contain a manufacturing defect that may cause increased risk of leakage. This defect presents a risk of incidental exposure to biological hazards associated with direct contact with patient specimens.

Healthcare facilities and diagnostic laboratories that received these products should cease use and contact Meridian Bioscience Inc. for instructions regarding return or replacement of affected vials.

Consumers and healthcare providers should report any incidents related to these products to Meridian Bioscience Inc. and the FDA.

The recalled product

Product: Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
Manufacturer: Meridian Bioscience Inc
Category: Medical Device — Diagnostic / Laboratory Equipment
Hazard: manufacturing-defect
leakage-risk
biological-exposure
Affected units: 571

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Meridian Bioscience Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Meridian Bioscience Inc

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