MEDLINE INDUSTRIES, LP – Northfield Recall 89493
Description: 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.
MEDLINE INDUSTRIES, LP – Northfield Recall 89493 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0678-2022 |
| Event ID | 89493 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US Distribution was made to IL, FL, LA, MS, NC, OH, and TX. |
| Quantity | 19 kits |
| Recall Reason | The product was incorrectly shipped at room temperature rather than refrigerated. |
| Device Classification | 20220302 |
| Device Code Info | Lot numbers 750030M481, Exp. 4/29/2022; 750030N482, Exp. 12/2/2022; and 750030N483, Exp. 5/17/2023. |
| Center Classification Date | 20220224 |
| Recall Initiation Date | 20220125 |
| Recalling Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Initial Notification | Letter |
| Similar To |