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U.S. Department of Health and Human Services

Class 2 Device Recall LumiraDx SARSCoV2 Ag Test Strip Kit

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 Class 2 Device Recall LumiraDx SARSCoV2 Ag Test Strip Kitsee related information
Date Initiated by FirmJanuary 11, 2021
Date PostedFebruary 17, 2021
Recall Status1 Terminated 3 on December 03, 2021
Recall NumberZ-1132-2021
Recall Event ID 87259
Product Classification Coronavirus antigen detection test system. - Product Code QKP
ProductLumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.
Code Information Catalog #:L016000109048 Lot #: 5000269 (GM2000238), 5000280 (GM2000232), 5000306 (GM2000261) (Updated 3/15/2021) 5000323 (GM2000354), 6000142 (GM2000296), 6000100 (GM2000322)
FEI Number 3012642695
Recalling Firm/
Manufacturer		 LumiraDx
221 Crescent St
Waltham MA 02453-3475
For Additional Information ContactTim Blicharz
617-621-9775
Manufacturer Reason
for Recall		Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary treatment or quarantine.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 01/28/2021, Lumiradx issued Urgent Medical Device Recall notices to customers via letter notifying customers the potential of false positive results in specified lots of LumiraDx SARS-CoV-2 Antigen (Ag) Test Strip. A false positive test result of a patient could result in potential exposure to unnecessary treatment or quarantine. (Updated 3/15/2021) On 2/26/2021, Lumiradx issued a second Urgent Medical Device Recall notice to customers via letter expanding the recall to include 3 additional lots. These lots are subject to recent feedback from a small number of customers regarding a small to moderate elevation in numbers of reported false positive patient test results.
Quantity in Commerce3,274,272 strips (Updated 3/15/2021 added 69,168 strips)
DistributionWorldwide distribution. US states of CA, GA, PA, SD. (Updated 3/15/2021) Austria, Germany, Ireland, Italy, Lebanon, Netherlands, Slovenia, Spain, United Kingdom.
Total Product Life CycleTPLC 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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