Detect Headquarters: Medical Device Recall in 2023 - (Recall #: Z-0879-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Detect Covid-19 Test Product/Model Number: 21205

Product Classification:

Class II

Date Initiated: December 8, 2022

Date Posted: January 11, 2023

Recall Number: Z-0879-2023

Event ID: 91300

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.

Status: Ongoing

Product Quantity: 10142 (US); 960 OUS

Code Information:

HY263, HY264, and HB264 Expiration 01JAN2023

Distribution Pattern:

Domestic distribution nationwide. Foreign distribution to Hong Kong.

Voluntary or Mandated:

Voluntary: Firm initiated