ACCESS SARS-CoV-2 Antigen Extraction Solution recalled for potential false positive results
Beckman Coulter is recalling ACCESS SARS-CoV-2 Antigen Extraction Solution nationwide because the assay test may generate false positive results, leading to incorrect diagnosis.
What this means for you
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: FDA Class II medical device recall where the extraction solution may generate false positive COVID-19 test results leading to incorrect diagnosis. No illnesses, injuries, or deaths reported; this is a risk-of-harm product without reported actual harm, meeting the High severity criterion.
Plain-English summary
Beckman Coulter Inc. is recalling all lots of the ACCESS SARS-CoV-2 Antigen Extraction Solution nationwide. This extraction solution is used in SARS-CoV-2 antigen assay testing. A total of 3,672 units were distributed across the United States (Alabama, Alaska, Arizona, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, West Virginia, and Wisconsin) and internationally to New Zealand and Libya.
The affected extraction solution may cause the SARS-CoV-2 antigen assay to generate false positive results, incorrectly identifying individuals as positive for SARS-CoV-2 when they are not infected. These false positive results could lead to incorrect diagnosis and inappropriate treatment decisions.
The recalled product
- Product
- ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
- Manufacturer
- Beckman Coulter Inc.
- Category
- Medical Device — Diagnostic Test
- Hazard
- false-positive
- incorrect-diagnosis
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)
- All Lots
Distribution
Distributed nationwide across the United States.
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