Beckman Coulter Access 2 Immunoassay System Recall for Thermal Component Defects
Beckman Coulter is recalling four Access 2 Immunoassay Systems because missing thermal components may cause internal temperature excursions, delaying patient result reporting.
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, but the hazard is a delay in reporting results rather than a direct physical injury or death, fitting the Moderate category for low-risk operational issues without reported harm.
Plain-English summary
Beckman Coulter Inc. is recalling four units of the Access 2 Immunoassay System, Remanufactured, Catalog No. 386220. The affected units are identified by serial numbers 505143, 504805, 501368, and 504231. These instruments are in vitro diagnostic devices used to determine analyte concentrations in human body fluids. The recall covers one unit in the United States, with the remaining units distributed in Morocco and Venezuela.
The recall is due to the lack of updated thermal components. This defect may make the instruments more susceptible to internal case temperatures exceeding the 18 to 36 degrees Celsius operating range. When this occurs, the instrument generates SYS flags and will not report results until the internal temperature returns to the acceptable operating range.
This situation may cause a delay in the reporting of patient results. No injuries or illnesses have been reported in connection with this recall. Users should contact Beckman Coulter for instructions on how to resolve the issue.
The recalled product
- Product
- Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.
- Manufacturer
- Beckman Coulter Inc.
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 (4)
- Serial No. 505143
- 504805
- 501368
- 504231
Distribution
Distribution scope not specified by the agency.
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