Beckman Coulter recalls ACCESS SARS-CoV-2 Antigen tests (REF: C68668) due to potential false positives. This may lead to incorrect COVID-19 diagnoses. All lots are affected.
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
Beckman Coulter is recalling all ACCESS SARS-CoV-2 Antigen tests (REF: C68668) because they can produce false positive results, which might cause incorrect COVID-19 diagnoses. This affects anyone using the test for home or clinical purposes.
The test may show a positive result for SARS-CoV-2 when no infection is present. This false positive could lead to unnecessary isolation, treatment, or anxiety. The risk is limited to incorrect diagnosis rather than physical harm.
Anyone who purchased or uses the Beckman Coulter ACCESS SARS-CoV-2 Antigen test (REF: C68668) for COVID-19 testing. People most at risk are those who rely on the test for accurate diagnosis.
Check for the product name 'ACCESS SARS-CoV-2 Antigen' with reference number REF: C68668. All lots are affected, so any version of this test is included in the recall.
Look for the unique identifier (UDI) (01) 15099590742713 on the test packaging.
The recall does not state that the test is unsafe; it only mentions a potential for false positive results.
Check for the product name 'ACCESS SARS-CoV-2 Antigen' with reference number REF: C68668. All lots are affected.
The recall does not specify a stop-use instruction; it only notes the potential for false positives.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2255-2021 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2255-2021 from Beckman Coulter. 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.
