Beckman Coulter Recalls UniCel DxH 800 Cellular Analysis System
Beckman Coulter is recalling the UniCel DxH 800 Cellular Analysis System because it may fail to detect blasts in some blood samples.
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 that may fail to detect a critical condition (blasts) in blood samples, representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Beckman Coulter Inc. is recalling the UniCel DxH 800 Coulter Cellular Analysis System (Catalog No. 629029, B24465, B24802, B68304). The recall involves 4,657 units total, with 2,067 units distributed in the United States. The product was distributed worldwide, including to numerous countries in Europe, Asia, the Americas, and the Middle East.
The recall was initiated because the system may not flag or detect blasts in some blood samples in rare situations. Beckman Coulter determined that additional clarification for the Blast Suspect messages is necessary due to limitations in the available technology and sample limitations. The recall covers all serial numbers for the affected catalog numbers.
Healthcare facilities and users of the UniCel DxH 800 system should contact Beckman Coulter for instructions on how to proceed. The company is providing clarification to ensure that the limitations of the technology are properly understood by users.
The recalled product
- Product
- UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304
- 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 (1)
- Serial Numbers: All
Distribution
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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