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# FDA Alert on BD Covid-19 Reagents
- URL: https://www.fdaweb.com/fda-alert-on-bd-covid-19-reagents/
- Published: 2020-07-06T12:00:00.000Z
- Updated: 2026-09-14T16:19:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147127

An FDA safety alert is warning about an increased risk of a false positive result with Becton Dickinson’s BD SARS-CoV-2 Reagents for the BD Max System test. In one study, the manufacturer found 3% of results were false positive for Covid-19, the [alert says](https://www.fda.gov/medical-devices/letters-health-care-providers/false-positive-results-bd-sars-cov-2-reagents-bd-max-system-letter-clinical-laboratory-staff-and?ref=fdaweb.com). The agency recommends that laboratories consider any positive result presumptive from tests using the BD SARS-CoV-2 Reagents for the BD Max System, and to consider confirming this with an alternate authorized test.  
  
The test is only authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 to perform moderate and high complexity tests. It is designed to detect viral nucleic acid from the virus that causes Covid-19 in upper respiratory specimens, such as nasal swabs.