# PRENETICS LIMITED · 89-08 · HONG KONG SAR — FDA import alert red lists: firms subject to detention without physical examination

For PRENETICS LIMITED · 89-08 · HONG KONG SAR, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is HONG KONG SAR; product is Circle HealthPod Rapid Detention System for Covid 19; product code is 83 Q - - LW COVID-19 test home collection kit devices; date published is 11/15/2021; address is 701-706,K11 Atelier King's Road , 728 King's Road , Quarry Bay, HONG KONG SAR, verified against its source on 2026-09-16.

- **Firm:** PRENETICS LIMITED _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** HONG KONG SAR _(verified: appears in the quote below)_
- **Address:** 701-706,K11 Atelier King's Road , 728 King's Road , Quarry Bay, HONG KONG SAR _(verified: appears in the quote below)_
- **Date published:** 11/15/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - LW COVID-19 test home collection kit devices _(verified: appears in the quote below)_
- **Product:** Circle HealthPod Rapid Detention System for Covid 19 _(verified: appears in the quote below)_

## What the source says

> PRENETICS LIMITED Date Published : 11/15/2021 701-706,K11 Atelier King's Road , 728 King's Road , Quarry Bay, HONG KONG SAR 83 Q - - LW COVID-19 test home collection kit devices Date Published: 11/15/2021 Desc: Circle HealthPod Rapid Detention System for Covid 19

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).