Recall Z-0554-2022 ยท JTO Discs, Strips And Reagents, Microorganism Differentiation
MEDLINE INDUSTRIES, LP - Northfield
HARDY DIAGNOSTICS CatScreen, 25dsk/vial
| Date | Dec 1, 2021 |
| Status | Terminated |
| Reason | Product stored incorrectly in temperature controlled setting instead of refrigeration. |
| Root cause | Process control |
| Action | Medline notified consignees on 12/01/2021, via first class mail letter titled URGENT RECALL NOTIFICATION. Customers were instructed to immediately check stock for affected product, quarantine any affected product on hand, complete and return the response form indicating product destroyed, and notify customers if the product was further distributed. |
| Quantity | 100 units (4 packs, 25 per pack) |
| Distribution | US Nationwide distribution in the state of California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960996 | M. CAT BUTYRATE DISK Hardy Diagnostics, Apr 18, 1996 |