Recall Z-0520-2024 ยท IGG Formaldehyde (Formalin, Formol)
Meridian Bioscience Inc
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
| Date | Dec 8, 2023 (initiated Oct 19, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | Meridan issued Urgent Medical Device Correction letters via email on 10/19/23 to Distributors and End-Users. Letter states reason for recall, health risk and action to take: Identify and segregate any remaining inventory. REQUIRED ACTIONS FOR PARA-PAK CLEAN VIAL, CATALOG 900312, LOT 509940Q: " Identify and segregate any remaining inventory. " Discard remaining Inventory of Para-Pak Clean Vial, Catalog 900312, Lot 509940Q in accordance with local, state, and/or federal regulations. Record quantity discarded. o Contact Meridian Technical Support at 1-800-343-3858 to coordinate product replacemen |
| Quantity | 201 Cases |
| Distribution | Nationwide Foreign: Italy |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K792705 | PARA-PAK FORMALIN Meridian Diagnostics, Inc., Jan 21, 1980 |