Reported Feb 10, 2021 · Terminated
Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis…
Biomeme, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomeme, Inc. · 1015 Chestnut St · Philadelphia, PA · 19107-4316
Is this the product you have?
- 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.
- Lot codes and dates
- Device Reference/Catalog Number (Black) - 1000003, (white) - 1000018. Software version 6.4.3 EUA - Emergency Use Authorization
- Amount recalled
- 147 systems
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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