Beckman Coulter UniCel DxH 800 Hematology Analyzer Recall for Platelet Errors
Beckman Coulter is recalling UniCel DxH 800 analyzers because sporadic platelet results may be erroneously elevated without system flags, potentially leaving thrombocytopenia unrecognized.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized."
Plain-English summary
Beckman Coulter Inc. is recalling the UniCel DxH 800 Coulter Cellular Analysis System, including REF numbers 629029, B24465, B24802, B68304, B66445, and B63322. The recall involves 5,414 devices distributed worldwide, including the United States, Puerto Rico, and numerous foreign countries. The UniCel DxH 800 is an automated hematology analyzer used in clinical laboratories for in vitro diagnostic testing of whole blood, pre-diluted whole blood, and body fluids.
The recall was initiated due to complaints of sporadic erroneously elevated platelet results that occur without accompanying flags or system messages. This defect poses a risk that thrombocytopenia (low platelet count) may go unrecognized in patient screening. All current software versions of the device are impacted by this issue.
Clinical laboratories and healthcare facilities should contact Beckman Coulter Inc. for instructions on how to address the recall. The source text does not specify a particular action for individual consumers, as the product is intended for professional in vitro diagnostic use in clinical settings.
The recalled product
- Product
- UniCel DxH 800 Coulter Cellular Analysis System, REF numbers 629029, B24465, B24802, B68304, B66445, and B63322. Product Usage: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 5,414
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 current software versions are impacted
Distribution
Part of a larger recall action
This product is one of 3 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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Similar recalls
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