PlainRecalls
FDA Devices Moderate Class II Terminated

LumiraDx 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.

Reported: February 24, 2021 Initiated: January 11, 2021 #Z-1132-2021

Product Description

LumiraDx 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.

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.

Details

Recalling Firm
LumiraDx
Units Affected
3,274,272 strips (Updated 3/15/2021 added 69,168 strips)
Distribution
Worldwide distribution. US states of CA, GA, PA, SD. (Updated 3/15/2021) Austria, Germany, Ireland, Italy, Lebanon, Netherlands, Slovenia, Spain, United Kingdom.
Location
Waltham, MA

Frequently Asked Questions

What product was recalled? ▼
LumiraDx 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.. Recalled by LumiraDx. Units affected: 3,274,272 strips (Updated 3/15/2021 added 69,168 strips).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 24, 2021. Severity: Moderate. Recall number: Z-1132-2021.

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