Beckman Coulter UniCel DxH 900 Hematology Analyzer Recall for Platelet Errors
Beckman Coulter is recalling 341 UniCel DxH 900 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 341 units of the UniCel DxH 900 Coulter Cellular Analysis System (REF number C11478). 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 distributed worldwide, including US nationwide (including Puerto Rico), government and military facilities, and numerous foreign countries. All current software versions of the device are impacted. The product is an automated hematology analyzer used in clinical laboratories for in vitro diagnostic testing of whole blood, pre-diluted whole blood, and body fluids.
Healthcare facilities and laboratories should contact Beckman Coulter for instructions on how to address the software defect and ensure accurate patient results.
The recalled product
- Product
- UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized under document CR180294 and is currently marketed as a member of the instrument family of the DxH 800 cleared under K140911, per FDA s…
- Manufacturer
- Beckman Coulter Inc.
- Affected units
- 341
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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