Z-1451-2022Class II

LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control

Name: Z-1451-2022 LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Creator: LumiraDx
Published: 2022-06-24
License: https://open.fda.gov/license/

LumiraDx / initiated 2022-06-24 / Terminated

FDA source

LumiraDx began a recall of LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control on 2022-06-24. FDA classified it as Class II and gives the reason as "Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1451-2022
Classification: Class II
Status: Terminated
Initiated: 2022-06-24
Posted: 2022-07-22
Terminated: 2024-05-10
Recalling firm: LumiraDx
Product: LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Product code: QKO Reagent, Coronavirus Serological
Reason for recall: Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
FDA root cause: Under Investigation by firm
Action: The firm distributed an email titled "URGENT: MEDICAL DEVICE RECALL" dated 06/24/2022 to customers informing them of the removal of LumiraDx SARS-CoV-2 Antibody (Ab) Test Strips and Liquid Quality Control due to design changes implemented outside the approved EUA. The firm asks that customers immediately stop use of recalled devices and remove any remaining tests from stock. Any devices in stock are to be destroyed. Customers are asked to complete the provided Customer Destruction and Attestation form to indicate how much product is in stock and destroyed by customers. Forms are to be returned by email to [email protected]. Customers are also asked to evaluate whether prior test results generated using these tests may be incorrect and whether a patient should be retested using an FDA-authorized test. Customers that have knowledge of any quality issues or adverse events associated with recalled devices are to report these events to the LumiraDx and FDA via MedWatch. Customers with any questions are to call LumiraDx at 1-888-586-4721 or email [email protected]. The firm distributed a second email dated 07/11/2022 to inform customers of an expansion of this recall event to all units distributed in the US. Customers with any LumiraDx SARS-CoV-2 Antibody (Ab) Test Strips and Liquid Quality Control are to remove from stock and destroy on-site. Patients who were tested with recalled product are to have their clinical presentation and medical history evaluated to determine if prior test results generated using recalled product may have been incorrect and if re-testing with an FDA-authorized test is necessary. Customers are asked to return the provided attestation form to LumiraDx and forward the notification to any sites where recalled products were distributed.
Quantity in commerce: 99 units
Distribution: Domestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.
Product codes and lots: No UDI codes. Catalog No. L017080109002. Lot No. 2002201428 (Exp. 01-Sept-2022).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1451-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1450-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-21
Z-1451-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-21

Product code QKO

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)