FDA Device recall Z-2157-2017
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322
- FDA Device
- Class II
- terminated
- Published 2017-05-31
On 2017-05-31 the FDA classified a Class II recall of UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322 by Beckman Coulter, citing there is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2157-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-24 |
| Published | 2017-05-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.
Reason
There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.
Identifiers
| code_info | all software versions |
|---|
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-2157-2017%22
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