Beckman Coulter Recalls UniCel DxH 800 Hematology Analyzers
Beckman Coulter is recalling UniCel DxH 800 hematology analyzers because drain ports may plug, causing biohazard exposure or incorrect test 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 (biohazard/chemical exposure and incorrect diagnostic results) where specific injury or illness reports are not stated in the source text, fitting the High severity criteria.
Plain-English summary
Beckman Coulter Inc. is recalling the UniCel DxH 800 Coulter Cellular Analysis System, Part Number 629029. This device is a quantitative, automated hematology analyzer used in clinical laboratories for in vitro diagnostic testing, including complete blood counts and differential counts.
The recall is being conducted because the NRBC, Differential, or Reticulocyte mix chamber drain ports may become plugged by rubber pieces from specimen tube caps. This malfunction can result in biohazard or chemical exposure and/or the potential for generating incorrect test results.
A total of 1,281 units were distributed worldwide, with 693 units distributed in the United States. The affected units were distributed nationwide in the US and in numerous other countries. All serial numbers are affected. Users should contact Beckman Coulter for further instructions on how to address the issue.
The recalled product
- Product
- Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides…
- 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
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