Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Nucleic acid-based in vitro diagnostic devices for the detection of Recalled by Biomeme, Inc. Due to Users cannot complete testing due to a sign-error...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biomeme, Inc. directly.
Affected Products
Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number 1000003,1000018) with the Software Controller version 6.4.3. The cycler has a "baseboard" unit with firmware and associated software component that control motorized movements of the optical filter carriage used for PCR detection.
Quantity: 147 systems
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 9 states: CA, FL, IN, KY, MD, NY, OH, PA, TX
About Biomeme, Inc.
Biomeme, Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report