FDA Device recall Z-0237-2018
UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is…
- FDA Device
- Class II
- terminated
- Published 2017-12-20
On 2017-12-20 the FDA classified a Class II recall of UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is… by Beckman Coulter, citing the shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0237-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-03 |
| Published | 2017-12-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | AR, CA, HI, MD, OH, WA |
Product
UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)
Reason
The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
Identifiers
| code_info | Serial Number AZ06682 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class II · 2026-10-14 · Beckman Coulter - DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3…
FDA Device · Class II · 2026-10-14 · Beckman Coulter - Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C…
FDA Device · Class II · 2026-08-26 · Beckman Coulter
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0237-2018%22
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