Mindray recalls specific lots of M-30D hematology diluent for BC-3200/3600 analyzers that may cause elevated platelet counts in blood tests.
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.
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.
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.
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.
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.
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.
The recalled M-30D diluent may cause the hematology analyzer to produce elevated platelet counts in blood tests, which could lead to incorrect medical diagnoses.
The affected analyzers are Mindray BC-3200 and BC-3600 hematology analyzers when used with the recalled M-30D diluent.
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.
We’ve drafted a message you can send Mindray to request your refund or repair — edit it as you like.
Subject: Recall Z-1320-2018 — Mindray Mindray Hello, I own a Mindray that is covered by recall Z-1320-2018 from Mindray. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
