Beckman Coulter Recalls UniCel DxH 800 and DxH 600 Analysis Systems
Beckman Coulter is recalling UniCel DxH 800 and DxH 600 systems because optical degradation may delay reporting of specific blood cell 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 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 risk-of-harm product (medical device) 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 UniCel DxH 600 Coulter Analysis Systems. These devices are used for in vitro diagnostic purposes in clinical laboratories to screen patient populations.
The recall is due to optical degradation in the systems, which may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential, and reticulocytes. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
The recall involves 2,874 units total, with 1,696 units distributed in the United States. The devices were distributed worldwide to numerous countries including Canada, Australia, China, and the United Kingdom. Clinical laboratories should contact Beckman Coulter for further instructions on managing the affected equipment.
The recalled product
- Product
- UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
- 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)
- All serial numbers
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 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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