Beckman Coulter Recalls Sample Probe Cables for Immunoassay Systems
Beckman Coulter is recalling sample probe cables for UniCel immunoassay systems because nonconforming units may cause delays in reporting 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, and the hazard involves a delay in reporting results rather than direct physical injury or death, fitting the criteria for a moderate severity recall.
Plain-English summary
Beckman Coulter Inc. is recalling sample probe cables used in UniCel DxI 600 and 800 Access Immunoassay Systems, UniCel DxC 660i, 680i, and 860i, and UniCel DxC 880i Synchron Access Clinical Systems instruments. The recall involves 236 units total, with 70 units distributed in the United States and the remainder distributed worldwide to various countries.
The recall is being conducted because nonconforming sample probe cables may have been installed on newly manufactured or recently serviced instruments. The use of these nonconforming cables can cause a delay in reporting results. The cables are distributed to Beckman and non-Beckman service engineers for replacement of worn or damaged parts during field service calls.
Affected units are identified by Lot number 2014 and specific serial numbers listed in the agency's recall record. Consumers and service engineers should verify their equipment against the provided serial numbers and contact Beckman Coulter for further instructions regarding the replacement of these components.
The recalled product
- Product
- UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments…
- Manufacturer
- Beckman Coulter Inc.
- Hazard
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)
- Sample probe cables
Distribution
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