Beckman Coulter Recalls SARS-CoV-2 IgG Quality Control Cards
Beckman Coulter is recalling 276 units of ACCESS SARS-CoV-2 IgG Quality Control cards due to a label error regarding standard deviation values.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a minor labeling error (incorrect standard deviation values) without reported injuries or illnesses, fitting the Moderate severity criteria for low-risk contamination or labeling issues.
Plain-English summary
Beckman Coulter Inc. is recalling 276 units of ACCESS SARS-CoV-2 IgG Quality Control (QC) cards, catalog number C58964, lot number 922407. These products are intended for use on the Access Family of Immunoassay Systems only.
The recall was initiated because the QC cards contain a label error for the standard deviation (SD) values for one of the two quality control levels. This labeling discrepancy may affect the accuracy of quality control assessments performed using the affected cards.
The affected products were distributed worldwide, including nationwide in the United States and in specific countries such as Canada, Germany, and the United Kingdom. Users of these products should stop using the affected QC cards and contact Beckman Coulter for further instructions or replacement.
The recalled product
- Product
- ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 276
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)
- Catalog Number: C58964 UDI Code: 15099590738662 Lot Number: 922407
Distribution
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