---
title: "SD Biosensor, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall"
description: "Search SD Biosensor, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions."
url: https://isitonrecall.com/brand/sd-biosensor-inc/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Home](https://isitonrecall.com/) / Brand archive

# SD Biosensor, Inc. recall records

**2** reported ongoing

3 records in this archive. Latest source date May 5, 2023. 1 published notices do not supply a closure status.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## Records and reported status

May 5, 2023 FDA company announcement

### [Pilot: COVID-19 At-Home Test](https://isitonrecall.com/recall/fdapress-4d3134e290bada96-pilot-covid-19-at-home-test/)

Due to microbial contamination in the liquid buffer solution.

Not supplied Published notice; closure not supplied

Distribution: Not supplied

[Official source for Pilot: COVID-19 At-Home Test](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/recall-notice-sd-biosensor-inc-requests-discontinuation-use-and-disposal-specific-pilottm-covid-19)

Mar 31, 2023 FDA device enforcement

### [Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)](https://isitonrecall.com/recall/fda-device-z-1594-2023-pilot-covid-19-at-home-test-reference-number-9901-ncov-10g-catalog-number-99cov200l-en02-upc-code-88/)

The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.

Class I Reported ongoing

Distribution: US Nationwide.

[Official source for Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC C...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1594-2023%22)

Jan 31, 2022 FDA device enforcement

### [STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present...](https://isitonrecall.com/recall/fda-device-z-0719-2022-standard-q-covid-19-ag-home-test-standard-q-covid-19-ag-home-test-is-a-rapid-chromatographic-immunoa/)

Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.

Class I Reported ongoing

Distribution: U.S. Nationwide Distribution

[Official source for STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immu...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0719-2022%22)

## Reasons in these listed records

- Due to microbial contamination in the liquid buffer solution.
- The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.
- Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.

These examples come from this result page and are not a ranking of every recall reason.

## Checking SD Biosensor, Inc.

### Is there a recall on sd biosensor, inc. right now?

This archive contains 3 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

### How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier.

### Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

### What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices.

### Where can I find older records?

Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

## Keep checking

[Search SD Biosensor, Inc.](https://isitonrecall.com/check/?q=SD%20Biosensor%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)
