LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 An

FDA device recall Z-1132-2021 · posted 2021-02-17 · Terminated

Recall details

Recalling firm

LumiraDx

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.

Action taken

On 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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

QKP

Quantity 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.

Date initiated

2021-01-11

Date posted

2021-02-17

Date terminated

2021-12-03

Location

Waltham, MA