SARS-CoV-2 IgG II reagent may produce falsely elevated results in certain software versions
This diagnostic reagent may multiply test results by 1000x in certain software versions, leading to falsely elevated readings. The Class II recall affects 13,337 units distributed in the US and internationally.
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: This Class II recall involves a diagnostic reagent capable of multiplying test results by 1000x, creating significant risk of patient misdiagnosis through dramatically inflated antibody values. Without reported illnesses or injuries, the risk-of-harm classification places this in the High severity category per the rubric.
Plain-English summary
Beckman Coulter Inc. is recalling the Access SARS-CoV-2 IgG II Reagent (REF: C69057), a diagnostic reagent for detecting SARS-CoV-2 antibodies. Approximately 13,337 units have been distributed across the United States and internationally.
The reagent may produce test results multiplied by a factor of 1000 when run on systems using specific versions of the assay protocol file (APF) and access assay file (AAF). This multiplication results in falsely elevated numerical values that do not reflect actual antibody levels.
The U.S. Food and Drug Administration has classified this as a Class II recall. The issue affects the accuracy of diagnostic test results produced by affected systems.
The recalled product
- Product
- Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 13,337
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.
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