Beckman Coulter Recalls DxH Slidemaker Stainer Software Due to ID Errors
Beckman Coulter is recalling specific software versions for the DxH 600 and 800 Slidemaker Stainer systems because they allow the creation of multiple orders with the same specimen ID but different patient IDs.
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Beckman Coulter Inc. is recalling the UniCel DxH 600 Coulter Cellular Analysis System (Software Version 1.1.1.0, Part No. B23858) and the DxH 800 Slidemaker Stainer (Software version 3.0.2.0). The recall involves 666 units total, with 327 units distributed in the United States and the remainder distributed internationally to numerous countries including Canada, the United Kingdom, and Australia.
The recall is being conducted because the software for the DxH systems allows the creation of multiple orders with the same Specimen identification (ID) but different Patient identification when manually editing pending orders at the System Manager. This defect could potentially lead to specimen-patient mismatch errors.
Healthcare facilities and laboratories that have purchased or are using these specific software versions should contact Beckman Coulter for further instructions on how to address the issue. The source text does not specify a consumer action for individual patients, as the product is a medical device used in professional settings.
The recalled product
- Product
- UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a…
- 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 Part No. B23858
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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