Lower riskMedical device recall · FDA · Published January 5, 2021
Biomeme Nucleic Acid Test Devices May Not Work Due to Software Error
Biomeme recalls certain coronavirus test devices that may fail due to a software error causing incomplete testing. Affected units include Franklin Real-Time PCR Thermocyclers with specific model numbers and software version 6.4.3.
Users cannot complete testing due to a sign-error in the software component that controls the filter movement and results in an instrument failure and assay failure before results are generated.
Take action
Contact the company
📍Recalling firmBiomeme, Inc.1015 Chestnut St · Philadelphia, PA 19107-4316
“Biomeme Nucleic Acid Test Devices May Not Work Due to Software Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63467-biomeme-nucleic-acid-test-devices-may-not-work-due-to. Based on FDA recall #Z-0940-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0940-2021%22&limit=1).
Biomeme, Inc. recalled nucleic acid-based in vitro diagnostic devices for detecting 2019-novel coronavirus on Jan. 5, 2021, according to the FDA. The hazard is a software sign-error causing instrument and assay failure. The recall was voluntary.
How to tell if you have it
Brand: Biomeme
Product: Nucleic acid-based in vitro diagnostic devices for detection of 2019-novel coronavirus (2019-nCoV)
Device Reference/Catalog Number (Black): 1000003
Device Reference/Catalog Number (white): 1000018
Software version: 6.4.3
Units affected: 147 systems
The hazard
Users cannot complete testing due to a sign-error in the software component that controls the filter movement. This results in an instrument failure and assay failure before results are generated.
Context
GovInfoNow's records show Biomeme, Inc. has two other recalls on record since Oct. 23, 2020. Other recent recalls of similar products include DASH Rapid PCR Instrument Software Issue Recall (Oct. 22, 2025), Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026) and Biomerieux VITEK 2 AST-N447 Kit Recall (June 4, 2026).
How to tell if you have this one
Check if your device has model numbers 1000003 (black) or 1000018 (white) and software version 6.4.3. The devices were sold with an Emergency Use Authorization for coronavirus testing.
Brand
Biomeme
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Verify your device's model number and software version to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in 9 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Domestic: FL, TX, IN, KY, OH, NY, CA, PA, MD. Foreign: Canada, Zimbabwe.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Indiana, Kentucky, Maryland, New York, Ohio, Pennsylvania, Texas.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
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-0940-2021 (January 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0940-2021 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.