LumiraDx: Medical Device Recall in 2021 - (Recall #: Z-1312-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 3, 2021

Date Posted: April 7, 2021

Recall Number: Z-1312-2021

Event ID: 87366

Reason for Recall:

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

Status: Terminated

Product Quantity: 2186 devices

Code Information:

catalog #: L001000330001

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated