Beckman Coulter recalls SARS-CoV-2 antigen extraction solution due to potential false positive results affecting COVID-19 testing accuracy. No remedy specified in official notice.
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
Beckman Coulter is recalling their SARS-CoV-2 antigen extraction solution because it may cause false positive results in COVID-19 tests. This could lead to incorrect diagnoses if used improperly.
The extraction solution may produce false positive results when used in SARS-CoV-2 antigen tests. This means a person might be incorrectly diagnosed with COVID-19 when they do not have the virus. The risk is limited to test accuracy, not immediate physical harm.
People who purchased or use the ACCESS SARS-CoV-2 Antigen Extraction Solution for at-home or lab testing. Those with limited testing experience may be at higher risk of misdiagnosis.
The product is labeled as 'ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only'. All lots are affected, including the UDI: (01)15099590743017.
Verify the product label matches the described extraction solution with the UDI code (01)15099590743017.
The official notice states the product may cause false positive results, but does not specify if it is unsafe for use.
The recall notice does not provide a remedy, so no action is required beyond checking if you have the product.
The official notice does not mention any physical injury risk, only potential false positive test results.
We’ve drafted a message you can send Beckman Coul: Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-2258-2021 — Beckman Coul: Inc. Beckman Coul: Inc. Hello, I own a Beckman Coul: Inc. that is covered by recall Z-2258-2021 from Beckman Coul: Inc.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
