FDA Device recall Z-3101-2017
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of t…
- FDA Device
- Class II
- terminated
- Published 2017-09-06
On 2017-09-06 the FDA classified a Class II recall of UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of t… by Beckman Coulter, citing the firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3101-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-20 |
| Published | 2017-09-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | US |
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
The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation.
Identifiers
| code_info | P/N A85371AA20; Catalog No. 775222 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3101-2017%22
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