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U.S. Department of Health and Human Services

Class 2 Device Recall SARSCoV2 Antibody (Ab) Test Strip

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  Class 2 Device Recall SARSCoV2 Antibody (Ab) Test Strip see related information
Date Initiated by Firm June 24, 2022
Date Posted July 22, 2022
Recall Status1 Open3, Classified
Recall Number Z-1450-2022
Recall Event ID 90479
Product Classification Reagent, coronavirus serological - Product Code QKO
Product LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
Code Information No UDI codes. Catalog No. L017000109024. Lot No. 5000599 (Exp. 08-Mar-2022), 5000602 (Exp. 10-Mar-2022), 5000612 (Exp. 23-Mar-2022), 5000613 (Exp. 24-Mar-2022), 5000614 (Exp. 25-Mar-2022), 5000617 (Exp. 16-Apr-2022), and 5000676 (Exp. 25-Aug-2022).
Recalling Firm/
Manufacturer		 LumiraDx
221 Crescent St
Waltham MA 02453-3475
For Additional Information Contact Colleen 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
Action The 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 Commerce 635 units
Distribution Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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