Hematology Diluent M-53D used with BC-5390 Hematology Analyzer — Class II medical device recall Z-1321-2018
Terminated recall by Mindray DS USA, Inc. dba Mindray North America, reported 2018-04-18, distributed in CA, MI, NC, PR, TX, WA. Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with B
| Recall number | Z-1321-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2018-01-24 |
| Classified | 2018-04-09 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2019-04-19 |
| Distributed | CA, MI, NC, PR, TX, WA |
| Quantity | 496 |
| Lot numbers | 2016111302, 2016112301, 2016121401, 2017010701, 2017041106, 2017060105 |
| Model numbers | 105-007867-00 |
Product
Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) The M-53D diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-5390 Hematology Analyzer.
Reason for recall
Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzer may cause the system to produce an elevated platelet background count.
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-1321-2018. 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.