The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a recall: Software Issue
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…
Why was The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a recalled?
The firm has become aware of nine reports by a single customer that the software made false positive calls. The investigation determined that the root cause is the higher than expected amber-to-red co-excitation in the assay.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Revision 2020-03-24
- 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…
- Recalling firm
- Biomeme, Inc.
- Quantity
- 105
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of CA, IN, NY, OH, PA, and the countries of Canada, Singapore, Zimbabwe, and Dominican Republic.
- Recall date
- December 9, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)