Biomeme PCR Thermocycler Recalled Due to Software Error Preventing Test Completion
Biomeme, Inc. is recalling 147 Franklin Real-Time PCR Thermocycler systems because a software error causes instrument failure, preventing users from completing 2019-nCoV tests.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a software error preventing test completion, with no reported injuries or illnesses.
Plain-English summary
Biomeme, Inc. is recalling 147 Franklin Real-Time PCR Thermocycler systems (Reference/Catalog Numbers 1000003 and 1000018) used for nucleic acid-based in vitro diagnostic testing for 2019-novel coronavirus (2019-nCoV). The recall is due to a sign-error in the software component that controls the movement of the optical filter carriage. This error results in instrument failure and assay failure before results are generated, meaning users cannot complete testing.
The affected devices are distributed domestically in Florida, Texas, Indiana, Kentucky, Ohio, New York, California, Pennsylvania, and Maryland, as well as in Canada and Zimbabwe. The devices operate with Software Controller version 6.4.3 and are associated with an Emergency Use Authorization (EUA).
Users should stop using the affected systems and contact Biomeme, Inc. for further instructions on the recall. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- 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…
- Manufacturer
- Biomeme, Inc.
- Affected units
- 147
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Device Reference/Catalog Number (Black) - 1000003
- (white) - 1000018. Software version 6.4.3 EUA - Emergency Use Authorization
Distribution
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