Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Recalled by Beckman Coulter, Inc. Due to When the UniCel DxH Slidemaker Stainer and UniCel...

Date: October 7, 2019
Company: Beckman Coulter, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Beckman Coulter, Inc. directly.

Affected Products

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 film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

Quantity: 1,056 (418 US, and 638 OUS)

Why Was This Recalled?

When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is slightly bent, there is a potential for cell carryover from the previous sample, and erroneous results could be reported from the slide review. Erroneous results may be reported from the laboratory which may trigger unnecessary or inappropriate patient treatment.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Beckman Coulter, Inc.

Beckman Coulter, Inc. has 79 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report