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.
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 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.
- Affected units
- 3,843
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 2 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Beckman Coulter Inc.
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
- High
Same hazard · inaccurate results
See all →- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
- Highepoc BGEM BUN Test Card for epoc Blood Analysis System
FDA (Devices) · 2026-05-06
- HighAbbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results
FDA (Devices) · 2026-05-06
Similar recalls
- HighSARS-CoV-2 Antigen Calibrators May Produce False Positive Test Results
FDA (Devices) · 2021-08-18
- HighBeckman Coulter SARS-CoV-2 Test Recalled for False Positive Risk
FDA (Devices) · 2021-08-18
- ModerateBeckman Coulter Recalls SARS-CoV-2 IgG Quality Control Cards
FDA (Devices) · 2021-01-27
- HighBeckman Coulter Access SARS-CoV-2 Antigen Recalled for False Negative Risk
FDA (Devices) · 2021-06-02
- HighACCESS SARS-CoV-2 Antigen Extraction Solution recalled for potential false positive results
FDA (Devices) · 2021-08-18
- HighBeckman Coulter SARS-CoV-2 Antigen QC Reagent Recalled Due to False Positive Risk
FDA (Devices) · 2021-08-18