Recall Z-0678-2022 ยท LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
MEDLINE INDUSTRIES, LP - Northfield
meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.
| Date | Jan 25, 2022 |
| Status | Terminated |
| Reason | The product was incorrectly shipped at room temperature rather than refrigerated. |
| Root cause | Storage |
| Action | The recalling firm, Medline Industries, LP, issued "URGENT RECALL NOTIFICATION MEDLINE INDUSTRIES, INC. IMMEDIATE ACTION REQUIRED" letters dated 1/25/2022 via first class mail on 1/25/2022. The letters were flagged that immediate action was required and the product was identified and the reason for recall was explained. The required actions instructed the customer to: 1) immediately check their stock for the affected item number and lot numbers listed in the attachment. Quarantine all affected product. 2) The customer was to complete and return the response form after completion to indicat |
| Quantity | 19 kits |
| Distribution | US Distribution was made to IL, FL, LA, MS, NC, OH, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971585 | IMMUNOCARD STAT! ROTAVIRUS Meridian Diagnostics, Inc., Aug 20, 1997 |