FDA company announcement
Pilot: COVID-19 At-Home Test
Due to microbial contamination in the liquid buffer solution.
Not suppliedPublished notice; closure not supplied
Distribution: Not supplied
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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. Source coverage and dates.
Records and reported status
Official source for Pilot: COVID-19 At-Home Test
FDA device enforcement
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
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 IReported ongoing
Distribution: US Nationwide.
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...
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 IReported ongoing
Distribution: U.S. Nationwide Distribution
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 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 and the agency's current notices.
Where can I find older records?
Use monthly 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.