Beckman Coulter Recalls UniCel DxH Analysis Systems for Optical Degradation
Beckman Coulter is recalling UniCel DxH800 and DxH600 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 medical device where a defect (optical degradation) poses a risk of harm by delaying the reporting of critical diagnostic results, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Beckman Coulter Inc. is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems. The recall is due to optical degradation that may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential, and reticulocyte.
The affected units are distributed worldwide, including in the United States, Canada, Australia, and numerous other countries. The source text does not specify the total number of units recalled, specific lot numbers, or the exact distribution dates.
Healthcare facilities and users of these systems should stop using the affected units and contact Beckman Coulter for instructions on how to proceed. The recall is intended to prevent delays in the reporting of critical blood test results.
The recalled product
- Product
- Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact with blood samples.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
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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