COULTER DxH Diluent — Class II medical device recall Z-1616-2015
Terminated recall by Beckman Coulter Inc., reported 2015-05-20, distributed in PR. Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 a
| Recall number | Z-1616-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2015-04-13 |
| Classified | 2015-05-14 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2015-10-01 |
| Distributed | PR |
| Countries outside the US | AR, BR, CA, CL, CO, HK, IN, LB, MX, PA, PH, QA, SG, TH, TT, TW, UY |
| Lot numbers | 3099980, 3512190 |
| Model numbers | 628017, A59956 |
| Expiration dates | 2015-04-17 |
Product
COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells.
Reason for recall
Beckman Coulter has received an increased number of complaints related to Hemoglobin (HGB) on UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems. The use of the DxH Diluent lots listed in the recall notice may eventually result in a compromised HGB chamber.
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-1616-2015. 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.