Beckman Coulter Recalls UniCel DxH 600 Hematology Analyzers for Platelet Errors
Beckman Coulter is recalling 2,059 UniCel DxH 600 hematology analyzers because they may produce erroneously elevated platelet results without warning, potentially masking low platelet counts.
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 2,059 UniCel DxH 600 Coulter Cellular Analysis Systems (REF number B23858). The recall is due to complaints of sporadic erroneously elevated platelet results that occur without flags or system messages. This defect may cause thrombocytopenia (low platelet count) to go unrecognized in patient testing.
The affected devices are benchtop hematology analyzers used for in vitro diagnostic testing of whole blood, pre-diluted whole blood, and body fluids. The recall covers all current software versions of the instrument. The devices were distributed worldwide, including US nationwide (including Puerto Rico), government and military facilities, and numerous foreign countries.
Healthcare facilities and laboratories should contact Beckman Coulter for instructions on how to address the issue. The source text does not specify a specific action for consumers, as these are professional medical devices.
The recalled product
- Product
- UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858. Product Usage: Note: The DxH 600 hematology analyzer is the same instrument as the DxH 800 (K140911), except that it is a benchtop unit with no instrument cart, computer stand, and no connectivity…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 2,059
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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