Product Safety Recalls

Product Recall Tracker

LumiraDx Recall 90479

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

LumiraDx Recall 90479 Information

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
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied. is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.