FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer
- Recall number
- Z-0238-2018
- Recalling firm
- Beckman Coulter Inc.
- Product
- UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer
- Status
- Terminated
- Initiated
- 2017-11-03
- Posted
- not on file
- Terminated
- 2018-06-19
- Reason
- The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
- Root cause
- Device Design
- Action
- The firm notified its consignees of the recall on 11/03/2017 by letter. The letter stated the issue and provided the following instructions: "To avoid a biohazardous spill, do not use the right (green) position of the Single-Tube Station for sample aspiration until the shield is removed. You may remove the shield following the instructions in Attachment 1 or contact your local Beckman Coulter Representative for further assistance."
- Quantity
- 3 units
- Distribution
- CA, AR, HI, CA, OH, WA, MD, Canada, Japan
- Lot, serial or model codes
- Serial Numbers: AW09034, AV40142, AU19113
- 510(k) numbers
- ["K140911"]
- PMA numbers
- not on file
- Product code
- GKZ
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28