LumiraDx issued an urgent device recall regarding a software update for its SARS-CoV-2 antigen test.
The company received a customer complaint regarding a suspected false-positive result with the antigen test on Dec. 29, 2020. An investigation into the complaint identified a manufacturing issue that resulted ina. small number of sequential test strips in certain batches having the potential to produce false-positives.
LumiraDx determined that approximately 1% of test strips are affected within 24 lots that were distributed in Europe. No reports of patient harm were presented to the company in relation to the issue.
The company identified the root cause of the issue and immediately implemented changes to its manufacturing process and updated its QC release and test procedures to reflect such changes.
In order to continue testing with the LumiraDx SARS-CoV-2 Ag test, users must install software version 1.21 immediately, as the software identifies the specific test strip ID numbers that could potentially indicate false-positive results and prevents such strips from being used.
When a user inserts an affected test strip, the instrument will instruct the user to discard the test strip and the remaining strips from the opened box. LumiraDx said in the safety notice that it will replace all affected test strips, free of charge.