Beckman Coulter Recalls UniCel DxH 800 and DxH 600 Systems
Beckman Coulter is recalling UniCel DxH 800 and DxH 600 systems due to a risk of specimen misidentification when the Primary Identifier is set to Tube Position ID.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of specimen misidentification, which is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Beckman Coulter Inc. is recalling the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. The recall involves 5,282 units total, with 2,877 units distributed in the United States. The affected systems are identified by specific catalog numbers and a list of serial numbers provided in the official recall notice.
The recall is being issued because there is a possibility of specimen misidentification on stand-alone DxH 800 and DxH 600 units where the Primary Identifier is configured to Tube Position ID. This configuration error could lead to incorrect patient results if the system relies on tube position rather than a unique identifier to track samples.
The affected units were distributed to facilities in the United States and numerous international locations, including Canada, the United Kingdom, Germany, France, and Japan. Healthcare facilities using these systems should check their serial numbers against the list provided by the FDA and contact Beckman Coulter for instructions on how to resolve the issue.
The recalled product
- Product
- UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System).
- Manufacturer
- Beckman Coulter Inc.
- Hazard
Distribution
Distributed in 1 state:
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