UniCel DxH 800 Coulter Cellular Analysis System — Class II medical device recall Z-2157-2017
Terminated recall by Beckman Coulter Inc., reported 2017-05-31, distributed nationwide. There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern
| Recall number | Z-2157-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2017-04-24 |
| Classified | 2017-05-24 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2018-05-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BG, BR, CA, CH, CN, CO, CR, CZ, DE, DZ, EC, ES, FR, GB, GR, HK, HR, HU, IE, IL, IN, IT, JO, JP, KR, KW, LB, LT, MA, MX, MY, NL, NZ, OM, PA, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, TH, TR, TT, TW, UY, VN, ZA |
| Model numbers | 629029, B24465, B24802, B63322, B66445, B68304 |
Product
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.
Reason for recall
There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.
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-2157-2017. 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.