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Terminated

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.

FDA Recall Z-1312-2021 · Posted None

Recalling FirmLumiraDx
Recall StatusTerminated
Product CodeQKP
Date Initiated2021-02-03
Date Terminated2022-07-13
Product Quantity2186 devices

Reason for Recall

Two lots of test strips failed QC testing using blank buffer due to false positives.

Firm 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.

Root Cause

Process design

Distribution Pattern

US nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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