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.
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 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.
- Affected units
- 3,672
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 4 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 4 products in this recall →Related recalls
Same manufacturer · Beckman Coulter Inc.
See all →- SevereBeckman Coulter IQ200 Hematology Analyzers Recalled for Check Valve Defect
FDA (Devices) · 2026-10-21
- SevereBeckman Coulter DxU 840m and 850m Iris Recalled for Check Valve Defect
FDA (Devices) · 2026-10-21
- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighBeckman Coulter DxC 500 AU Analyzer Software Defect Recall
FDA (Devices) · 2026-08-26
Same hazard · false positives
See all →- HighNeuMoDx Diagnostic Cartridges Recalled for Label Misplacement Risk
FDA (Devices) · 2023-08-09
- HighBioPlex 2200 Anti-CCP Reagent Pack Recalled for Reduced Diagnostic Specificity
FDA (Devices) · 2023-04-19
- HighAbbott Alinity m Resp-4-Plex Amp Kit Recalled for False Positive Results
FDA (Devices) · 2022-12-28
- SevereAbbott Alinity m Resp-4-Plex Respiratory Diagnostic Kit Recalled for False Positive Results
FDA (Devices) · 2021-10-20
- HighFilmArray Pneumonia Panel diagnostic test kits recalled for false results
FDA (Devices) · 2021-06-30
Similar recalls
- HighBeckman Coulter Access SARS-CoV-2 Antigen Recalled for False Negative Risk
FDA (Devices) · 2021-06-02
- HighSARS-CoV-2 IgG II reagent may produce falsely elevated results in certain software versions
FDA (Devices) · 2021-06-30
- SevereFDA Recalls Accula SARS-CoV-2 Test for False Positive Risk
FDA (Devices) · 2022-05-18
- HighCOVID-19 antibody test assay recalled due to insufficient validation evidence
FDA (Devices) · 2021-09-29
- ModerateBeckman Coulter Recalls SARS-CoV-2 IgG Quality Control Cards
FDA (Devices) · 2021-01-27
- HighSARS-CoV-2 IgG II Calibrator Results Potentially Multiplied by 1000
FDA (Devices) · 2021-06-30