ELLUME LTD Recall 88801
Description: Ellume COVID-19 Home Test
ELLUME LTD Recall 88801 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0183-2022 |
| Event ID | 88801 |
| Event Description | Ellume COVID-19 Home Test |
| Product Type | Devices |
| Distribution | U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided |
| Quantity | 427,994 kits |
| Recall Reason | Due to a higher rate of false positive test results. |
| Device Classification | 20211117 |
| Device Code Info | Catalogue number I-SRS-C-01 Master Lot Numbers: 21047-4; 21047-5; 21089-1; 21117-1; PF06Z-H; 21099-1; 21124-1; 21125-1; PF03X-H; PF057-H; PF05W-H; PF069-H; PF06E-H; PF06N-H; PF06Z-H; PG080-H; PG08H-H; PH08X-H; |
| Center Classification Date | 20211110 |
| Recall Initiation Date | 20211001 |
| Recalling Firm | ELLUME LTD |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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