Recall Z-1719-2025 ยท MHI Giardia Spp.
MEDLINE INDUSTRIES, LP - Northfield
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
| Date | May 2, 2025 (initiated Mar 24, 2025) |
| Status | Open, Classified |
| Reason | A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 3/24/25 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3. Please destroy any affected inventory. Medline will issue credit for the product based |
| Quantity | 56 boxes |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983399 | GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY Genzyme Diagnostics, Jan 11, 1999 |