FDA Device recall Z-2651-2014
Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a dil…
- FDA Device
- Class II
- terminated
- Published 2014-09-24
On 2014-09-24 the FDA classified a Class II recall of Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a dil… by Beckman Coulter, citing beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. This will result in fail….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2651-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-25 |
| Published | 2014-09-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement of hemoglobin.
Reason
Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. This will result in failed Daily Checks on the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems.
Identifiers
| code_info | Lot No. 3510470, 3510480, 3510490, 3510500, 3510510, 3510520, 3510530, 3510540, 3510550, 3510570, 3510580, 3510590, 3510600, 3510610, 3510620, 3510630, 3510690. |
|---|
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-2651-2014%22
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