Beckman Coulter DxH Slidemaker Stainer Floor Stand Recall for Sharp Edges
Beckman Coulter is recalling 41 DxH Slidemaker Stainer Floor Stands because missing vinyl caps expose sharp edges on drawer slides, posing a physical injury risk to operators.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a physical injury risk from sharp edges without reported fatalities or serious injuries, fitting the Moderate criteria for low-risk physical hazards.
Plain-English summary
Beckman Coulter Inc. is recalling 41 units of the UniCel DxH Slidemaker Stainer Instrument System, specifically the optional floor stand, due to a manufacturing defect. The recall was initiated because the floor stands were shipped with missing vinyl caps, which exposes sharp edges on the drawer slides of the reagent cabinet.
The sharp edges on the drawer slides may expose operators to physical injury when they are replacing reagents and waste containers. The affected units are distributed worldwide, including nationwide in the United States and in Belgium, France, Hong Kong, Italy, Spain, and Switzerland.
Healthcare facilities and operators should check their inventory for the affected part numbers (775222 and A96152) and serial numbers listed in the recall notice. If a unit is affected, operators should stop using the floor stand and contact Beckman Coulter for instructions on repair or replacement.
The recalled product
- Product
- UniCel DxH Slidemaker Stainer Instrument System, PN 775222. 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 variety of fixatives, stains…
- 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 (20)
- Part Number(s) 775222 and A96152
- Serial #s-MP010
- MP023
- MP026
- AS23001
- AS23002
- AS25003
- AS25004
- AS25005
- AS33008
- AS33009
- AS33010
- AS33011
- AS37013
- AS38014
- AS38015
- AS39016
- AS39017
- AS40018
- AS44012
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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