Mindray recalls Hematology Diluent M-53D (20L) used with BC-5390 analyzers due to potential elevated platelet counts. Affected lots include 2017060105, 2017041106, 2017010701, 2016121401, 2016112301, 2016111302.
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.
Mindray is recalling Hematology Diluent M-53D (20L) used with BC-5390 analyzers because certain lots may cause the analyzer to show higher than normal platelet counts. This could lead to incorrect blood test results if not addressed.
The diluent may cause the BC-5390 analyzer to display elevated platelet counts in blood tests. This could lead to incorrect test results if the affected diluent is used, potentially affecting diagnosis and treatment decisions.
Users of Mindray BC-5390 Hematology Analyzers with the affected M-53D diluent lots (2017060105, 2017041106, 2017010701, 2016121401, 2016112301, 2016111302) are most at risk. Healthcare professionals using these specific lots should check their inventory.
Check the lot number on the M-53D diluent container. Affected lots are 2017060105, 2017041106, 2017010701, 2016121401, 2016112301, and 2016111302. The product is a 20L container used with Mindray BC-5390 analyzers.
Look for the lot number on the M-53D container to see if it matches the affected lots listed: 2017060105, 2017041106, 2017010701, 2016121401, 2016112301, or 2016111302.
The M-53D diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells, used with the Mindray BC-5390 Hematology Analyzer.
Affected lots are 2017060105, 2017041106, 2017010701, 2016121401, 2016112301, and 2016111302.
No, but you should check the lot number to ensure you are not using an affected lot. If you have an affected lot, contact Mindray for guidance.
We’ve drafted a message you can send Mindray to request your refund or repair — edit it as you like.
Subject: Recall Z-1321-2018 — Mindray Mindray Hello, I own a Mindray that is covered by recall Z-1321-2018 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.
