Biomeme, Inc. recalls
Every recall we track for Biomeme, Inc. — 3 in all, from 2020–2021 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
3 recalls since 2017.
All FDA recall records for Biomeme, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 1 |
| 2021 | 0 | 0 | 2 | 0 | 2 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Biomeme, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Biomeme, Inc. recalls
3 shown- Lower riskMedical device
Biomeme, Inc. recalls Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2
Biomeme recalls SARS-CoV-2 test kits with shorter RPC Buffer shelf life. The buffer stabilizes for two days instead of one week at room temperature. No action needed for users.
BiomemeOct 20, 2021 - Lower riskMedical device
Biomeme, Inc. recalls Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis
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.
BiomemeJan 5, 2021 - Stop using nowMedical device
Biomeme, Inc. recalls The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used
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.
BiomemeOct 23, 2020
Biomeme, Inc. recall questions
How many recalls has Biomeme, Inc. had?
3 recalls from Biomeme, Inc. are on record with U.S. safety agencies, from 2020–2021.
What is the most recent Biomeme, Inc. recall?
Biomeme, Inc. recalls Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2, dated Oct 20, 2021. Every Biomeme, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Biomeme, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Biomeme, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.