FDA Device recall Z-0147-2014
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automat…
- FDA Device
- Class II
- terminated
- Published 2013-11-13
On 2013-11-13 the FDA classified a Class II recall of UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automat… by Beckman Coulter, citing beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 629029) and UniCel DxH 600 Coulter Cellular Analysis System (PN B23858) because the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0147-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-24 |
| Published | 2013-11-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a tabletop or with a floor stand. The DxH 600 is available as an analyzer for use on a tabletop only.
Reason
Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 629029) and UniCel DxH 600 Coulter Cellular Analysis System (PN B23858) because the company's internal investigation indicates that specific lots of check valves used in several locations within the DxH 800 and DxH 600 systems may fail. A failure may result in an air or liquid leak at the VCS Waste Chamb
Identifiers
| code_info | Part Numbers: 629029 for DxH 800 and B23858 for DxH 600. Serial Numbers: AS49437 AV11229 AV23436 AV28032 AT0506…Part Numbers: 629029 for DxH 800 and B23858 for DxH 600. Serial Numbers: AS49437 AV11229 AV23436 AV28032 AT05062 AU32435 AT27373 AT09132 AV06132 AV06143 AT21266 AT21268 AT23307 AS46410 AS46411 AU48003 AV05097 AT27346 AT40554 AU23277 AV05082 AV05092 AV11205 AT06076 AT09112 AT09114 AT16214 AT18235 AV11214 AV11217 AN30069 AS07008 AT09116 AS40361 AU05048 AU05054 AT48658 AS49426 AS49429 AV01023 AV01025 AM48043 AV06003 AT40542 AS15064 AT30380 AV01015 AS12050 AV06004 AV06151 AS12051 AS12052 AT01004 AU25303 AT36497 AT36499 AT36509 AV06127 AV06130 AV11231 AV14273 AV14275 AV27546 AV06141 AV01009 AV05104 AV09187 AV09192 AV09179 AU42632 AV06152 AV11238 AV14278 AV14283 AV28554 AV28559 AV23449 AV18362 AV09180 AV18364 AV24456 AV22393 AV11234 AV02072 AV05098 AV09184 AV02046 AV09191 AV09196 AV09197 AV24452 AT18242 AV09182 AV02051 AV02068 AV02076 AV06139 AV11236 AV12241 AV14287 AV28031 AV06147 AV112 |
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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-0147-2014%22
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