Stop using nowMedical device recall · FDA · Published October 23, 2020
Biomeme SARS-CoV-2 Test May Give False Positives - Stop Using Now
Biomeme recalls its SARS-CoV-2 test due to false positive results from software errors. Users should stop using the test immediately to avoid incorrect health decisions.
The firm has become aware of nine reports by a single customer that the software made false positive calls. The investigation determined that the root cause is the higher than expected amber-to-red co-excitation in the assay.
Take action
Contact the company
📍Recalling firmBiomeme, Inc.1015 Chestnut St · Philadelphia, PA 19107-4316
“Biomeme SARS-CoV-2 Test May Give False Positives - Stop Using Now.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64060-biomeme-sars-cov-2-test-may-give-false-positives-stop. Based on FDA recall #Z-0513-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0513-2021%22&limit=1).
The FDA announced on Oct. 23, 2020, that Biomeme, Inc. is recalling The Biomeme SARS-CoV-2 Real-Time RT-PCR Test due to false positive results caused by software errors. The agency issued recall number Z-0513-2021 for the voluntary Class II action affecting 105 units distributed worldwide.
How to tell if you have it
Brand: Biomeme
Product: The Biomeme SARS-CoV-2 Real-Time RT-PCR Test
Controller models: Biomeme: 1000013 (Android Smartphone w/ Biomeme Go Mobile App) and Biomeme: 1000012 (Rugged Android Smartphone w/ Biomeme Go Mobile App)
Quantity: 105 units
The hazard
The firm has become aware of nine reports by a single customer that the software made false positive calls. The investigation determined that the root cause is the higher than expected amber-to-red co-excitation in the assay.
Context
GovInfoNow's records show Biomeme, Inc. has two other recalls on record since Jan. 5, 2021, including a March 24, 2020 revision issue and an Oct. 20, 2021 recall for shorter buffer shelf life. Other recent recalls of similar products include BioFire Respiratory Panel 2.1 (June 24, 2026), BioFire Spotfire Respiratory Panel Recall (April 1, 2026), and Biomerieux VITEK 2 AST-N447 Kit Recall (June 4, 2026).
How to tell if you have this one
Check for the Biomeme SARS-CoV-2 Real-Time RT-PCR Test kit with the Franklin thermocycler and Biomeme Go mobile app. The product was sold with specific Android smartphones (model 1000013 or 1000012) and the software version from March 24, 2020.
Brand
Biomeme
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop using the test now
The test may give false positive results, so stop using it immediately to avoid incorrect health decisions.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of CA, IN, NY, OH, PA, and the countries of Canada, Singapore, Zimbabwe, and Dominican Republic.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Indiana, New York, Ohio, Pennsylvania.
Recall timeline
FDA terminated this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0513-2021 (October 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0513-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.