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U.S. Department of Health and Human Services

Class 2 Device Recall LumiraDx Instrument

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  Class 2 Device Recall LumiraDx Instrument see related information
Date Initiated by Firm February 03, 2021
Create Date March 26, 2021
Recall Status1 Terminated 3 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
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 2		 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.
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