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U.S. Department of Health and Human Services

Class 2 Device Recall SARSCoV2 Antibody (Ab) Liquid Quality Control

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 Class 2 Device Recall SARSCoV2 Antibody (Ab) Liquid Quality Controlsee related information
Date Initiated by FirmJune 24, 2022
Date PostedJuly 22, 2022
Recall Status1 Terminated 3 on May 10, 2024
Recall NumberZ-1451-2022
Recall Event ID 90479
Product Classification Reagent, coronavirus serological - Product Code QKO
ProductLumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Code Information No UDI codes. Catalog No. L017080109002. Lot No. 2002201428 (Exp. 01-Sept-2022).
Recalling Firm/
Manufacturer		 LumiraDx
221 Crescent St
Waltham MA 02453-3475
For Additional Information ContactColleen McMillen
917-344-9360
Manufacturer Reason
for Recall		Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm distributed an email titled "URGENT: MEDICAL DEVICE RECALL" dated 06/24/2022 to customers informing them of the removal of LumiraDx SARS-CoV-2 Antibody (Ab) Test Strips and Liquid Quality Control due to design changes implemented outside the approved EUA. The firm asks that customers immediately stop use of recalled devices and remove any remaining tests from stock. Any devices in stock are to be destroyed. Customers are asked to complete the provided Customer Destruction and Attestation form to indicate how much product is in stock and destroyed by customers. Forms are to be returned by email to customerservices.US@lumiradx.com. Customers are also asked to evaluate whether prior test results generated using these tests may be incorrect and whether a patient should be retested using an FDA-authorized test. Customers that have knowledge of any quality issues or adverse events associated with recalled devices are to report these events to the LumiraDx and FDA via MedWatch. Customers with any questions are to call LumiraDx at 1-888-586-4721 or email customerservices.US@lumiradx.com. The firm distributed a second email dated 07/11/2022 to inform customers of an expansion of this recall event to all units distributed in the US. Customers with any LumiraDx SARS-CoV-2 Antibody (Ab) Test Strips and Liquid Quality Control are to remove from stock and destroy on-site. Patients who were tested with recalled product are to have their clinical presentation and medical history evaluated to determine if prior test results generated using recalled product may have been incorrect and if re-testing with an FDA-authorized test is necessary. Customers are asked to return the provided attestation form to LumiraDx and forward the notification to any sites where recalled products were distributed.
Quantity in Commerce99 units
DistributionDomestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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