Data Foundry

Medical device recalls 2017

UniCel DxH Slidemaker Stainer — Class II medical device recall Z-0238-2018

Terminated recall by Beckman Coulter Inc., reported 2017-12-20, distributed in AR, CA, HI, MD, OH, WA. The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open

Recall numberZ-0238-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBeckman Coulter Inc., Brea, CA, United States
Recall initiated2017-11-03
Classified2017-12-13
Reported by FDA2017-12-20
Terminated2018-06-19
DistributedAR, CA, HI, MD, OH, WA
Countries outside the USCA, JP
Quantity3 units
Serial numbersAU19113, AV40142, AW09034
Model numbers75222

Product

UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer

Reason for recall

The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0238-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.