The Recall Desk
HighFDA (Devices)·Z-2255-2021·Announced 2021-08-18

Beckman Coulter SARS-CoV-2 Test Recalled for False Positive Risk

Beckman Coulter is recalling its ACCESS SARS-CoV-2 Antigen test (REF C68668) because it may produce false positive results, potentially leading to incorrect diagnoses.

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 device with the potential to generate false positive results, leading to incorrect diagnoses. No reported illnesses or hospitalizations documented.

Plain-English summary

Beckman Coulter Inc. is recalling the ACCESS SARS-CoV-2 Antigen test (REF: C68668) because it may generate false positive results. This could result in incorrect diagnosis of SARS-CoV-2 infection.

The affected product was distributed nationwide throughout the United States, as well as in New Zealand and Libya. A total of 3,672 units are affected across all manufacturing lots. Healthcare providers and laboratories using this test should be aware of this risk of false positive results.

The recalled product

Product
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
  • false-positives
  • diagnostic-error

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.

Related recalls

Same category