CLASS II Device recall · Reported 18 Apr 2018 · FDA Enforcement Report
Hematology Diluent M-53D used with BC-5390 Hematology Analyzer recalled
Mindray DS USA is recalling Hematology Diluent M-53D used with BC-5390 Hematology Analyzer, distributed in California, Michigan, North Carolina, Puerto Rico, Texas, Washington. The recall was initiated on 24 Jan 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1321-2018
- FDA event ID
- 79556
- Recalling firm
- Mindray DS USA, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jan 2018
- FDA classified
- 9 Apr 2018
- Reported
- 18 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 24 Jan 2018 | Recall initiated by company | |
| 9 Apr 2018 | Classified by FDA | +75 days |
| 18 Apr 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot Numbers: 2017060105 ¿ 2017041106 ¿ 2017010701 ¿ 2016121401 ¿ 2016112301 ¿ 2016111302
Where was it sold?
US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 79556This product is part of a recall event; the main page for the event is Hematology Diluent used with and Hematology Analyzer recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Hematology Diluent used with and Hematology Analyzer recalled | Mindray DS USA | Other | 6 states |
More recalls from Mindray DS USA
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,671| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Techno-Path Multichem AE Unassayed Level recalled | Techno-path Manufacturing | Potency & Assay | Nationwide |
| Device | CLASS II | Techno-Path Multichem AE Unassayed Level recalled | Techno-path Manufacturing | Potency & Assay | Nationwide |
| Device | CLASS II | Techno-Path Multichem AE Unassayed Level recalled | Techno-path Manufacturing | Potency & Assay | Nationwide |
| Device | CLASS II | MAS Omni Immune PRO Liquid Assayed Integrated Immunoassay recalled | Microgenics | Potency & Assay | Nationwide |
| Device | CLASS II | The ABL90 Flex and ABL90 Flex Plus analyzers are intended recalled | Radiometer Medical ApS | Labeling Errors | Nationwide |