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Para-Pak LV-PVA / 10% Formalin
MERIDIAN BIOSCIENCE, INC. · Model 300112 · UDI-DI 00840733102608
7
510(k) clearances
1
Adverse events
1
Recalls
18
Facilities
Description
Para-Pak Systems provide standardized procedures for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites. Systems are designed for easy use by individuals not trained in microbiological procedures and afford an excellent means of minimizing the adverse effects of delay in specimen transport.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-19 | Meridian Bioscience Inc | 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 |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.