COULTER ISOTON 4 Diluent — Class II medical device recall Z-2481-2015
Terminated recall by Beckman Coulter Inc., reported 2015-09-09, distributed nationwide. Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may e
| Recall number | Z-2481-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2015-07-22 |
| Classified | 2015-08-28 |
| Reported by FDA | 2015-09-09 |
| Terminated | 2015-12-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | BM, CA, GT, HK, MX, PA, TT, TW |
| Quantity | 710 units |
| Lot numbers | 18203F-18206F |
| Model numbers | 8547148 |
Product
COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.
Reason for recall
Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette.
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-2481-2015. 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.