Mindray Hematology Diluent M-30D Recall: Elevated Platelet Count Risk
Mindray recalls specific lots of M-30D hematology diluent for BC-3200/3600 analyzers that may cause elevated platelet counts in blood tests.
Lower-risk 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 Analyzers may cause the system to produce an elevated platelet background count.
Contact the company
What happened, in plain English
Mindray is recalling certain lots of M-30D hematology diluent used with BC-3200 and BC-3600 analyzers because they may cause false high platelet counts in blood tests. This could lead to incorrect medical diagnoses if not addressed. Read more at govinfonow.com/recall/72102-mindray-hematology-diluent-m-30d-recall-elevated-platelet-count-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/72102-mindray-hematology-diluent-m-30d-recall-elevated-platelet-count-risk · Updated August 28, 2026 · FDA enforcement record: FDA #Z-1320-2018
Cite this page
“Mindray Hematology Diluent M-30D Recall: Elevated Platelet Count Risk.” GovInfoNow, updated August 28, 2026. https://govinfonow.com/recall/72102-mindray-hematology-diluent-m-30d-recall-elevated-platelet-count-risk. Based on FDA recall #Z-1320-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1320-2018%22&limit=1).
Why it’s dangerous
The recalled diluent may cause the hematology analyzer to show higher platelet counts than actually present in blood samples. This could lead to false positive results for platelet disorders, potentially causing unnecessary medical interventions.
Who’s affected
Lab technicians and healthcare providers using Mindray BC-3200 or BC-3600 hematology analyzers with specific lots of M-30D diluent. Patients receiving blood tests with these devices may be at risk of inaccurate results.
How to tell if you have this one
Check if your M-30D diluent has part number 105-005405-00 (2 x 5.5L container) or 105-005406-00 (20L container). Look for specific lot numbers listed in the recall notice.
- Brand
Mindray- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1320-2018 | Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L container), (2) 105-005406-00 (20L container) The M-30D Diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-3200 and BC-3600 Hematology Analyzer.; (1) 105-005405-00 (2 x 5.5L container) Lot Numbers: 2017060906, 2017041207, 2017042707, 2017041104, 2016122301, 2016112901, 2016060401, 2016052701, 2016052101, 2016050301; (2)105-005406-00 (20L container) Lot Numbers: 2017041104, 2016121901, 2016051801, 2016050301 | 4838 |
| Z-1321-2018 | 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.; Lot Numbers: 2017060105 ¿ 2017041106 ¿ 2017010701 ¿ 2016121401 ¿ 2016112301 ¿ 2016111302 | 496 |
What to do — step by step
Check Diluent Lot Numbers
Identify the lot numbers on your M-30D diluent container to determine if it is affected. Affected lots include 2017060906, 2017041207, 2017042707, 2017041104, 2016122301, 2016112901, 2016060401, 2016052701, 2016052101, 2016050301 for the 5.5L container and 2017041104, 2016121901, 2016051801, 2016050301 for the 20L container.
Where it went and when
Where it was distributed
Distributed in 5 states and Puerto Rico.
FDA distribution: “US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Michigan, North Carolina, Puerto Rico, Texas, Washington.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the diluent immediately?
No, but you should check the lot numbers to see if your diluent is affected. If it is, you may need to replace it with a non-recalled lot.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1320-2018 (January 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1320-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 28, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.