UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System — Class II medical device recall Z-3101-2017
Terminated recall by Beckman Coulter Inc., reported 2017-09-06, distributed nationwide. The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installa
| Recall number | Z-3101-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2017-06-20 |
| Classified | 2017-09-01 |
| Reported by FDA | 2017-09-06 |
| Terminated | 2021-04-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CH, CL, CN, CZ, DK, ES, FR, GB, GR, HK, IL, IN, IT, JP, KR, MA, PT, TR, TW, VN, ZA |
| Quantity | 310 units |
| Reason classes | packaging |
| Model numbers | 775222 |
Product
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: Allows for the differentiation of white blood cells, facilitates the characterization of red blood cells and platelets, and aids in the identification of blood components and cellular abnormalities.
Reason for recall
The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation.
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-3101-2017. 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.