FDA Device recall Z-2732-2016
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System
- FDA Device
- Class II
- terminated
- Published 2016-09-14
On 2016-09-14 the FDA classified a Class II recall of UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System by Beckman Coulter, citing there is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2732-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-08 |
| Published | 2016-09-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | PR |
Product
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System).
Reason
There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID.
Identifiers
| code_info | Serial No. AZ28848 AZ20791 AZ20789 AZ25359 AZ25362 AM51052 AZ23820 AZ28405 AZ28406 AZ02009 AW23066 AW16273…Serial No. AZ28848 AZ20791 AZ20789 AZ25359 AZ25362 AM51052 AZ23820 AZ28405 AZ28406 AZ02009 AW23066 AW16273 AW02003 AV52153 AU44687 AU44682 AV09188 AY50973 AZ25374 AV09197 AZ03660 AZ06661 AW23164 AY10661 AT48671 AY17706 AV11202 AS24187 AU42604 AU42605 AU47775 AU47783 AU45705 AW02013 AT09135 AT18249 AT18247 AW05068 AW02059 AW12090 AU19248 AU19249 AU19248 AW02020 AV35049 AV38713 AU36511 AU36519 AY17711 AY04037 AY01034 AY17198 AV28561 AZ28855 AY42926 AY42921 AU44671 AY24762 AY24768 AU36524 AW16124 AW14113 AW45310 AV09167 AW26208 AV44863 AW35273 AW35269 AW23085 AZ12149 AU47757 AV44103 AW23167 AW20160 AW31265 AW31263 AV32042 AW23060 AW23061 AV49123 AV14278 AV14283 AZ12183 AZ12182 AU38543 AU40576 AV06152 AU42632 AZ10095 AZ10107 AZ12140 AZ12141 AZ12165 AZ12166 AV27520 AV27522 AW51368 AZ12146 AZ12145 AZ12148 AZ12147 AV28609 AV28610 AZ12151 AZ12153 AZ10109 AZ10101 AZ06687 AZ19767 AW16135 |
|---|
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-2732-2016%22
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