Beckman Coulter Recalls UniCel DxI 600 Access Immunoassay System Analyzer
Beckman Coulter is recalling the UniCel DxI 600 Access Immunoassay System Analyzer because non-conforming bushings may cause incorrect test results.
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 explicitly states there is only a 'remote probability' of incorrect results and does not report any injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling the UniCel DxI 600 Access Immunoassay System Analyzer. This in vitro diagnostic device is used to determine the concentration of various analytes in human body fluids. The recall involves 1 unit with Part Number A30260 and Serial Number 900781.
The recall was initiated because the device may have been manufactured with non-conforming bushings. According to the source text, these non-conforming bushings have a remote probability of generating incorrect results. The device was distributed worldwide, including in South Dakota, Germany, Lebanon, and China.
Users of the affected device should contact Beckman Coulter Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 1
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)
- Part Number A30260. Serial Numbers 900781.
Distribution
Distributed in 1 state:
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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