UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System — Class II medical device recall Z-2732-2016
Terminated recall by Beckman Coulter Inc., reported 2016-09-14, distributed in PR. There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary
| Recall number | Z-2732-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2016-08-08 |
| Classified | 2016-09-02 |
| Reported by FDA | 2016-09-14 |
| Terminated | 2017-04-29 |
| Distributed | PR |
| Countries outside the US | AU, BE, CA, CH, CN, CZ, DE, EC, EG, ES, FR, GB, GR, HK, HR, HU, IE, IL, IN, IT, JO, JP, KR, KW, LB, MA, MX, MY, NO, NZ, OM, PA, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, TH, TR, TT, TW, UY, VN |
| Serial numbers | AM19007, AM43032, AM44041, AM48043, AM51052, AN05001, AN05004, AN07015, AN07020, AN07022, AN10025, AN10027, AN10028, AN10031, AN10033, AN10034, AN10035, AN20046, AN20048, AN20049, AN20054, AN30062, AN30064, AN30067, AN30069 and 475 more |
| Model numbers | 629029, B23858, B24465, B24802, B68304 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2732-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.