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U.S. Department of Health and Human Services

Class 3 Device Recall LumiraDx

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  Class 3 Device Recall LumiraDx see related information
Date Initiated by Firm September 23, 2022
Date Posted October 26, 2022
Recall Status1 Open3, Classified
Recall Number Z-0135-2023
Recall Event ID 90998
Product Classification Coronavirus antigen detection test system. - Product Code QKP
Product LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit
Catalog #: L016080109002 (EUA)

The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality
control testing performed on the LumiraDx Instrument when used with
the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users
with assurance that the device is performing within specification
Code Information LQC Kit: 2002204017 Positive Control Vial: 1000 1710 0014 0141 Negative Control Vial: 1000 1720 0014 0142 Exp. Date: 01-Mar-2023
Recalling Firm/
Manufacturer		 LumiraDx
221 Crescent St
Waltham MA 02453-3475
Manufacturer Reason
for Recall		 Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs within batch 2002204017, which should have been assigned SARS-CoV-2 Ag lot numbers resulting in an error message and preventing use of the LQC
FDA Determined
Cause 2		 Error in labeling
Action LumiraDx issued Urgent Product Recall Notice and were provided with an attestation form to document product destruction at their facility via email on 23 September 2022. Letter states reason for recall, health risk and action to take: Immediately stop using the affected lots of LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Controls. " Remove from your stock any remaining affected kits of LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Controls as listed in Table 1. " Ensure any of the affected SARS-CoV-2 Antigen (Ag) Liquid Quality Controls are removed from your inventory are destroyed (not just thrown away), indicate the number of Liquid Quality Control kits that were destroyed, and sign the attestation form at the end of this notice verifying destruction of the affected SARS-CoV-2 Antigen (Ag) Liquid Quality Controls in your inventory. " Report any issues or adverse events with using the LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Controls to LumiraDx immediately or to the FDA via the MedWatch program. " Please forward this notice to additional testing sites if these products were further distributed within your system. " LumiraDx will provide replacement product over the course of the next few days. If you have any questions, contact LumiraDx Customer Services at customerservices.US@lumiradx.com or 1-888-586-4721.
Quantity in Commerce 83 kits
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 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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