FDA Device recall Z-1830-2014
Coulter DxH Cleaner 5L, Part No. 628022
- FDA Device
- Class II
- terminated
- Published 2014-07-02
On 2014-07-02 the FDA classified a Class II recall of Coulter DxH Cleaner 5L, Part No. 628022 by Beckman Coulter, citing beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1830-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-08 |
| Published | 2014-07-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | PR |
Product
Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components that come in contact with blood samples.
Reason
Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.
Identifiers
| code_info | Lot No. 3040200 3056140 3071360 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1830-2014%22
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