Beckman Coulter Recalls UniCel DxH 600 and DxH 800 Analysis Systems
Beckman Coulter is recalling UniCel DxH 600 and DxH 800 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 is classified as FDA Class II, and the hazard involves a delay in reporting critical diagnostic results, which fits the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Beckman Coulter Inc. is recalling the UniCel DxH 600 and UniCel DxH 800 Coulter Cellular Analysis Systems. These devices are used for in vitro diagnostic purposes in clinical laboratories to screen patient populations. The recall affects 164 units total, with 106 units located in the United States. The products were distributed worldwide, including in Canada, Australia, China, and numerous other countries.
The recall is being conducted because optical degradation in the devices may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential, and reticulocyte counts. This issue could impact the timeliness of diagnostic data available to healthcare providers.
Clinical laboratories and healthcare facilities that possess these devices should contact Beckman Coulter for instructions on how to proceed with the recall. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. 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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