Recall Z-0552-2022 ยท LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
MEDLINE INDUSTRIES, LP - Northfield
Premier Rotaclone, Rx only
| 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. An amended customer letter was sent on 12/17/2021. The explanation of the issue was updated. Instructions remained the same. |
| Quantity | 34 units |
| Distribution | US Nationwide distribution in the states of California and Massachusetts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K852969 | ROTACLONE ROTAVIRUS DIAGNOSTIC KIT Cambridge Bioscience Corp., Nov 5, 1985 |