UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System — Class II medical device recall Z-2692-2016
Terminated recall by Beckman Coulter Inc., reported 2016-09-07, distributed nationwide. Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the
| Recall number | Z-2692-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2016-08-04 |
| Classified | 2016-08-30 |
| Reported by FDA | 2016-09-07 |
| Terminated | 2016-10-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, CN, CZ, DE, ES, FR, GB, HK, HR, IL, IN, IT, JP, KR, KW, MX, MY, NZ, PH, PL, PT, QA, SA, SK, TH, TR, TT, TW, VN |
| Model numbers | 775222, B26647AC |
Product
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC 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
Reason for recall
Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System to reduce the potential for flammable liquids coming into contact with electrical components in the Stainer module possibly causing a fire.
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-2692-2016. 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.