Beckman Coulter Recalls UniCel DxH Slidemaker Stainer Devices Due to Bent Probe Risk
Beckman Coulter is recalling UniCel DxH Slidemaker Stainer devices because a bent dispense probe may cause cell carryover, leading to erroneous lab results and potential inappropriate patient treatment.
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. The hazard involves erroneous diagnostic results that may lead to inappropriate patient treatment, which fits the rubric for high-risk products where injury has not yet been reported.
Plain-English summary
Beckman Coulter, Inc. is recalling the UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II). These are fully automated slide preparation and staining devices used to aspirate whole-blood samples, smear blood films on microscope slides, and apply fixatives, stains, buffers, and rinse solutions.
The recall is due to a potential defect where the dispense probe may be slightly bent. This condition creates a risk of cell carryover from previous samples, which can result in erroneous results being reported from the laboratory. Such erroneous results may trigger unnecessary or inappropriate patient treatment.
A total of 1,056 units are affected, comprising 418 units in the United States and 638 units outside the US. The devices were distributed worldwide, including in the US and numerous international markets. Affected units are identified by specific catalog numbers (775222, B66705, C11477) and a long list of serial numbers provided in the official recall notice.
The recalled product
- Product
- UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood…
- 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)
- Catalog Number 775222. Serial numbers: AS39017
- AS40018
- AT35013
- AT35014
- AT35015
- AT35017
- AT35018
- AT40020
- AT40021
- AT40022
- AT40024
- AT40025
- AT40027
- AT40030
- AT45031
- AT45032
- AT45034
- AT45035
- AT49037
- AT49041
Distribution
Distributed nationwide across the United States.
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