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

FDA device recall Z-1451-2022 · posted 2022-07-22 · Terminated

Recall details

Recalling firm

LumiraDx

Reason for recall

Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

QKO

Quantity affected

99 units

Distribution

Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.

Date initiated

2022-06-24

Date posted

2022-07-22

Date terminated

2024-05-10

Location

Waltham, MA