Beckman Coulter DxH 600 Cellular Analysis System Recall for Blast Detection
Beckman Coulter is recalling the DxH 600 Cellular Analysis System because it may fail to detect blasts in some blood samples.
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 medical device with a potential for diagnostic error (failure to detect blasts), which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Beckman Coulter Inc. is recalling the DxH 600 Coulter Cellular Analysis System (Catalog No. B23858). The recall involves 1,282 units total, with 915 units distributed in the United States, including Puerto Rico. The product was also distributed to numerous countries worldwide.
The recall was initiated because the system may not flag or detect blasts in some blood samples. Beckman Coulter determined that additional clarification for the Blast Suspect messages is necessary. The company attributes this issue to limitations in the available technology as well as sample limitations.
This recall affects all serial numbers of the affected devices. Healthcare facilities and laboratories using this equipment should contact Beckman Coulter for further instructions on how to manage the recall and ensure patient safety.
The recalled product
- Product
- DxH 600 Coulter Cellular Analysis System, Catalog No. B23858
- 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)
- Serial Numbers: All
Distribution
Part of a larger recall action
This product is one of 2 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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