Class 2 Device Recall LumiraDx Instrument

• Date Initiated by Firm: February 03, 2021
• Create Date: March 26, 2021
• Recall Status: Terminated on July 13, 2022
• Recall Number: Z-1312-2021
• Recall Event ID: 87366
• Product Classification: Coronavirus antigen detection test system. - Product Code QKP
• Product: Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset.
• Code Information: catalog #: L001000330001
• FEI Number: 3012642695
• Recalling Firm/ Manufacturer: LumiraDx; 221 Crescent St; Waltham MA 02453-3475
• For Additional Information Contact: Tim Blicharz; 617-621-9775 Ext. 7382
• Manufacturer Reason for Recall: Two lots of test strips failed QC testing using blank buffer due to false positives.
• FDA Determined Cause: Process design
• Action: On 2/23/2020, LumiraDx issued an Urgent Device Medical Corrective Field Action notice to customers, advising them of a mandatory field corrective action in the form of a software update for the LumiraDx SARS-CoV-2 Antigen (Ag) Test.
• Quantity in Commerce: 2186 devices
• Distribution: US nationwide distribution.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.