Meridian Bioscience recalls Para-Pak Zn-PVA/10% Formalin vials due to manufacturing defect causing leakage and potential biological exposure risks during stool specimen handling.
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.
Meridian Bioscience is recalling Para-Pak Zn-PVA/10% Formalin vials that may leak, creating a risk of exposure to biological hazards from patient specimens. This affects stool collection and testing for intestinal parasites.
The vials have a manufacturing defect that can cause leakage. This leakage may lead to incidental exposure to biological hazards if patient specimens come into contact with the leaking vial.
Healthcare providers and labs using Para-Pak vials for stool specimen collection and testing for intestinal parasites are most at risk. Patients using these vials for home testing may also be affected.
Check for vials labeled 'Para-Pak Zn-PVA/10% Formalin' with catalog number 301012, UDI-DI 00840733101250, and lot number 509130Q. These vials were sold for stool specimen collection and testing for intestinal parasites.
Identify the vial by catalog number 301012, UDI-DI 00840733101250, and lot number 509130Q.
The vials have a manufacturing defect that may cause leakage, presenting a risk of incidental exposure to biological hazards from patient specimens.
Leakage could lead to exposure to biological hazards if patient specimens come into contact with the leaking vial.
Look for vials labeled 'Para-Pak Zn-PVA/10% Formalin' with catalog number 301012, UDI-DI 00840733101250, and lot number 509130Q.
We’ve drafted a message you can send Meridian Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-0520-2024 — Meridian Bioscience Meridian Bioscience Hello, I own a Meridian Bioscience that is covered by recall Z-0520-2024 from Meridian Bioscience. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
