Agency classClass IIOur severity:High FDA (Devices)·Z-0513-2021·Announced 2020-12-09

Biomeme SARS-CoV-2 PCR Test Recalled for False Positive Results

Biomeme is recalling 105 units of its SARS-CoV-2 Real-Time RT-PCR Test because the software made false positive calls due to assay issues.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. While false positives in diagnostic testing can lead to unnecessary medical interventions or anxiety, the source does not report any hospitalizations, serious injuries, or deaths, placing it in the High severity category rather than Severe.

Plain-English summary

Biomeme, Inc. is recalling 105 units of the Biomeme SARS-CoV-2 Real-Time RT-PCR Test. This molecular in vitro diagnostic test is used for the qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens. The recall includes the test components, the M1 Sample Prep Cartridge, the Go-Strips assay, the Franklin Real-Time qPCR Thermocycler, and associated Android smartphones with the Biomeme Go mobile app.

The recall was initiated after the firm became aware of nine reports from a single customer indicating that the software made false positive calls. An investigation determined that the root cause of these errors was higher than expected amber-to-red co-excitation in the assay. The affected products were distributed worldwide, including in the United States (specifically CA, IN, NY, OH, and PA) and in Canada, Singapore, Zimbabwe, and the Dominican Republic.

Consumers and healthcare providers who have purchased or received these products should stop using them and contact Biomeme, Inc. for instructions on how to return the products or obtain a refund. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro…
Manufacturer: Biomeme, Inc.
Category: Medical Device — In Vitro Diagnostic
Hazard: false-positive-result
software-error
Affected units: 105

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 (1)

Revision 2020-03-24

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Same manufacturer · Biomeme, Inc.

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Same hazard · false positive result