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 in process.
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 source text describes a functional defect that causes tests to be cancelled rather than a risk of serious injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling the Access 2 Family of Immunoassay Systems, Part No. 81600N. These are in vitro diagnostic devices 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, with 291 units in the United States. The affected serial numbers are 511527 through 511678 and 511681 through 512212. The product was distributed to multiple countries, including the United States, Canada, and various nations in Europe, Asia, Africa, and the Americas. Users should contact Beckman Coulter for further instructions on how to proceed with the recall.
The recalled product
- Product
- Access 2 Immunoassay Systems, Part No. 81600N 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 concentrations found in human body…
- 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 (2)
- Serial No. 511527 - 511678
- 511681 - 512212
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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