# SPRING HEALTHCARE SERVICES AG · 89-08 · SWITZERLAND — FDA import alert red lists: firms subject to detention without physical examination

For SPRING HEALTHCARE SERVICES AG · 89-08 · SWITZERLAND, 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 SWITZERLAND; product is COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | COVID-19 Rapid IgM/IgG Combined Antibody Assay | Spring COVID-19 IgM/IgG Rapid Test Cassette; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 05/14/2021; address is Obstgartenstrasse 5 , Affoltern Am Albis, Zurich SWITZERLAND, verified against its source on 2026-09-16.

- **Firm:** SPRING HEALTHCARE SERVICES AG _(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:** SWITZERLAND _(verified: appears in the quote below)_
- **Address:** Obstgartenstrasse 5 , Affoltern Am Albis, Zurich SWITZERLAND _(verified: appears in the quote below)_
- **Date published:** 05/14/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological _(verified: each item appears in the quote below)_
- **Product:** COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | COVID-19 Rapid IgM/IgG Combined Antibody Assay | Spring COVID-19 IgM/IgG Rapid Test Cassette _(verified: each item appears in the quote below)_

## What the source says

> SPRING HEALTHCARE SERVICES AG Date Published : 05/14/2021 Obstgartenstrasse 5 , Affoltern Am Albis, Zurich SWITZERLAND 83 Q - - KO Reagent, coronavirus serological Date Published: 05/14/2021 Desc: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) 83 Q - - KO Reagent, coronavirus serological Date Published: 05/14/2021 Desc: COVID-19 Rapid IgM/IgG Combined Antibody Assay 83 Q - - KO Reagent, coronavirus serological Date Published: 05/14/2021 Desc: Spring COVID-19 IgM/IgG Rapid Test Cassette

## 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/).