Beckman Coulter Recalls Ultrasonic Transducer Kits Due to Incorrect Screws
Beckman Coulter is recalling 82 Ultrasonic Transducer Kits because they may have been assembled with incorrect mounting screws.
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 source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Beckman Coulter Inc. is initiating a field action for 82 units of Ultrasonic Transducer Kits. These kits are intended for use with the Access Family of Immunoassay Systems, which includes the Access 2, UniCel DxI 800, UniCel DxI 600, UniCel DxC 600i, UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems.
The recall is being conducted because some of the kits were potentially assembled with incorrect mounting screws. The affected products were distributed worldwide, including in the United States, Australia, Canada, China, France, Hong Kong, Italy, Japan, Mexico, Portugal, Spain, Switzerland, Taiwan, and Turkey.
Users of these systems should contact Beckman Coulter for further instructions regarding the field action.
The recalled product
- Product
- Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC…
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 82
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 (5)
- Access 2 Immunoassay Systems
- Catalog Number: 81600N. UniCel DxI 600 Access Immunoassay Systems
- UniCel DxC 680i SYNCHRON Access Clinical Systems
- UniCel DxC 860i SYNCHRON Access Clinical Systems
- UniCel DxC 880i SYNCHRON Access Clinical Systems.
Distribution
Distributed nationwide across the United States.
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