Beckman Coulter Recalls Access 2 Immunoassay Systems Due to Circuit Board Defect
Beckman Coulter is recalling Access 2 Immunoassay Systems because a defective circuit board can cause the device to stop running and cancel tests.
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. The hazard involves the cancellation of in-process tests due to mechanical positioning errors, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure.
Plain-English summary
Beckman Coulter Inc. is recalling the Access 2 Family of Immunoassay Systems, specifically the Remanufactured Part No. 386220. These in vitro diagnostic devices are used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
The recall is being issued because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. These position errors cause the instrument to stop running and cancel tests that are in process.
A total of 851 units were distributed globally, with 291 units distributed in the United States. Affected geographies include the United States, Canada, Mexico, and numerous countries across Europe, Asia, Africa, and South America. Users should contact Beckman Coulter for further instructions regarding the affected serial numbers.
The recalled product
- Product
- Access 2 assay Immunoassay System, Remanufactured, Part No. 386220 Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte…
- 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 (20)
- Serial No. 501012
- 501110
- 501190
- 501224
- 501294
- 501371
- 501394
- 501403
- 501440
- 501443
- 501490
- 501501
- 501673
- 501681
- 501693
- 501861
- 501920
- 501926
- 501936
- 501970
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 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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