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LumiraDx Recall 90479

Description: LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control

LumiraDx Recall 90479 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1451-2022
Event ID90479
Event DescriptionLumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Product TypeDevices
DistributionDomestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.
Quantity99 units
Recall ReasonModification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
Device Classification20220727
Device Code InfoNo UDI codes. Catalog No. L017080109002. Lot No. 2002201428 (Exp. 01-Sept-2022).
Center Classification Date20220721
Recall Initiation Date20220624
Recalling FirmLumiraDx
Initial Notification E-Mail
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