The Recall Desk
HighFDA (Devices)·Z-1906-2021·Announced 2021-06-30

SARS-CoV-2 IgG II Calibrator Results Potentially Multiplied by 1000

Beckman Coulter's Access SARS-CoV-2 IgG II Calibrator may return test results inflated by up to 1000-fold due to software errors, potentially misrepresenting patient immune status.

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 recall involving a risk-of-harm medical device. The 1000-fold multiplication of test results represents a significant accuracy error that could affect clinical interpretation, but no illnesses, injuries, or adverse events have been reported. This meets the criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Beckman Coulter Inc. is recalling Access SARS-CoV-2 IgG II Calibrator units (REF C69058) due to a software defect that may cause test results to be falsely elevated.

The problem occurs when systems run certain versions of assay protocol files and access assay files. Under these conditions, SARS-CoV-2 IgG II numerical results may be multiplied by a factor of 1000, resulting in severely inflated values. This error could lead to misinterpretation of a patient's immune response and affect clinical decision-making regarding immunity status.

Approximately 3,843 units across all lot numbers have been distributed to facilities in 26 U.S. states, Puerto Rico, and multiple international locations. Laboratories and healthcare facilities currently using this calibrator should verify whether they are running affected software versions.

Healthcare providers should contact Beckman Coulter for updated software or alternative guidance to prevent the use of potentially inaccurate results in patient care.

The recalled product

Product
Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
Manufacturer
Beckman Coulter Inc.
Category
Medical Device — In Vitro Diagnostic / Calibrator
Hazard
  • inaccurate-results
  • calibration-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

Distribution scope not specified by the agency.

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