FDA Device Intelligence
HomeMERIDIAN BIOSCIENCE, INC. › Para-Pak 10% Formalin Fixative

Para-Pak 10% Formalin Fixative

MERIDIAN BIOSCIENCE, INC. · Model 900412 · UDI-DI 00840733102707

IGG Prescription
7
510(k) clearances
1
Adverse events
1
Recalls
18
Facilities

Description

Para-Pak based 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 transportation.

Recalls

DateFirmReason
2023-10-19Meridian Bioscience IncPlastic 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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data 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.