Detect Headquarters: Detect Covid-19 Test Product/Model Number: 21205

Recall number

Z-0879-2023

Recalling firm

Detect Headquarters

Product

Detect Covid-19 Test Product/Model Number: 21205

Status

Open, Classified

Initiated

2022-12-08

Posted

2023-01-04

Terminated

not on file

Reason

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

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

10142 (US); 960 OUS

Distribution

Domestic distribution nationwide. Foreign distribution to Hong Kong.

Lot, serial or model codes

HY263, HY264, and HB264 Expiration 01JAN2023

510(k) numbers

not on file

PMA numbers

not on file

Product code

QKP

Firm FEI

3018103650

Firm city

Guilford

Firm state

CT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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