Z-1312-2021Class II

Coronavirus antigen detection test system -

Name: Z-1312-2021 Coronavirus antigen detection test system -
Creator: LumiraDx
Published: 2021-02-03
License: https://open.fda.gov/license/

LumiraDx / initiated 2021-02-03 / Terminated / root cause: manufacturing process

FDA source

LumiraDx began a recall of Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly... on 2021-02-03. FDA classified it as Class II and gives the reason as "Two lots of test strips failed QC testing using blank buffer due to false positives". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1312-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-03
Posted: 2021-03-26
Terminated: 2022-07-13
Recalling firm: LumiraDx
Product: 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 code: QKP Coronavirus Antigen Detection Test System.
Reason for recall: Two lots of test strips failed QC testing using blank buffer due to false positives.
Root cause tag: manufacturing process
FDA root cause: Process design
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.
Quantity in commerce: 2186 devices
Distribution: US nationwide distribution.
Product codes and lots: catalog #: L001000330001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1312-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1312-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-07	2021-03-26

Product code QKP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)