FDA Device recall Z-2138-2023
COULTER DxH Diluent, REF 628017
- FDA Device
- Class II
- ongoing
- Published 2023-07-19
On 2023-07-19 the FDA classified a Class II recall of COULTER DxH Diluent, REF 628017 by Beckman Coulter, citing specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2138-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-31 |
| Published | 2023-07-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
Reason
Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.
Identifiers
| code_info | UDI DI 150995901HEMDILUENT5R; Container Number: 0001-0401: Lot numbers: Lot Numbers Beginning with 3541: 3541500,…UDI DI 150995901HEMDILUENT5R; Container Number: 0001-0401: Lot numbers: Lot Numbers Beginning with 3541: 3541500, 3541510, 3541520, 3541550, 3541610, 3541620, 3541670, 3541690, 3541750, 3541770, 3541790, 3541810, 3541830, 3541860, 3541880, 3541900, 3541910, 3541920, 3541930, 3541940, 3541950, 3541990; Lot Numbers Beginning with 3542: 3542010, 3542030, 3542050, 3542070, 3542110, 3542150, 3542170, 3542180, 3542190, 3542230, 3542250, 3542260, 3542270, 3542310, 3542350, 3542370, 3542450, 3542490, 3542510, 3542530, 3542570, 3542590, 3542610, 3542630, 3542650, 3542670, 3542720, 3542740, 3542760, 3542780, 3542800, 3542820, 3542840, 3542850, 3542900, 3542920, 3542940, 3542960, 3542980; Lot Numbers Beginning with 3543: 3543000, 3543020, 3543040, 3543050, 3543080, 3543120, 3543140, 3543160, 3543170, 3543180, 3543200, 3543220, 3543240, 3543280, 3543300, 3543320, 3543340, 3543360, 3543370, 3543390, 3543410, 3543430, 3543460, 3543480, 3543500, 3543540, 3543560, 3543580, 3543610, 354385 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2138-2023%22
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