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.
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: 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
- Affected units
- 3,672
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
Part of a larger recall action
This product is one of 4 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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