Z-0879-2023Class II

Detect Covid-19 Test Product/Model Number: 21205

Name: Z-0879-2023 Detect Covid-19 Test Product/Model Number: 21205
Creator: Detect Headquarters
Published: 2022-12-08
License: https://open.fda.gov/license/

Detect Headquarters / initiated 2022-12-08 / Open, Classified / root cause: design

FDA source

Detect Headquarters began a recall of Detect Covid-19 Test Product/Model Number: 21205 on 2022-12-08. FDA classified it as Class II and gives the reason as "There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0879-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-08
Posted: 2023-01-04
Recalling firm: Detect Headquarters
Product: Detect Covid-19 Test Product/Model Number: 21205
Product code: QKP Coronavirus Antigen Detection Test System.
Reason for recall: There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community.
Root cause tag: design
FDA root cause: Component design/selection
Action: On December 8, 2022, the firm notified affected enterprise/wholesale customers through email with subject line "URGENT: Voluntary Recall of Three Lots of Detect Covid-19 Tests". Direct customers were notified on December 12, 2022. Customers were instructed to locate unused tests from the affected lots and dispose of them. Customers may receive a refund for the recalled tests once they complete an acknowledgement form and return it to Detect.
Quantity in commerce: 10142 (US); 960 OUS
Distribution: Domestic distribution nationwide. Foreign distribution to Hong Kong.
Product codes and lots: HY263, HY264, and HB264 Expiration 01JAN2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0879-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0879-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-11	2023-01-04

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)