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ELLUME LTD Recall 88801

Description: Ellume COVID-19 Home Test

ELLUME LTD Recall 88801 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0183-2022
Event ID88801
Event DescriptionEllume COVID-19 Home Test
Product TypeDevices
DistributionU.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided
Quantity427,994 kits
Recall ReasonDue to a higher rate of false positive test results.
Device Classification20211117
Device Code InfoCatalogue 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 Date20211110
Recall Initiation Date20211001
Recalling FirmELLUME LTD
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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