Clinical Diagnostic Solutions recalls Medonic M16S hematology analyzers with serial numbers before 3/21/2019 due to possible misidentification of sample results and operator needle injury risk.
A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.
Clinical Diagnostic Solutions is recalling Medonic M16S hematology analyzers with serial numbers made before March 21, 2019. This recall is because the device might mix up sample tube positions, leading to wrong test results, and could cause operator injury from a needle sticking out.
The device may mix up sample tube positions, causing test results to be misidentified. This could lead to incorrect medical decisions. Additionally, the aspiration needle might become exposed, posing a risk of injury to the user.
Healthcare professionals who use the Medonic M16S hematology analyzers with serial numbers before March 21, 2019 are most at risk. This includes lab technicians and medical staff handling blood tests.
Check the serial number on the device. The recall applies to Medonic M16S hematology analyzers with serial numbers distributed before March 21, 2019.
Look for the serial number on the device to confirm if it was made before March 21, 2019.
Reach out to Clinical Diagnostic Solutions for further instructions on how to handle the device.
The US product code is 1400075 and the OUS product code is 1400011.
The device might mix up sample tube positions, leading to misidentified test results, and could cause operator injury from an exposed aspiration needle.
Check the serial number on the device. The recall applies to models with serial numbers distributed before March 21, 2019.
We’ve drafted a message you can send Clinical Diagnostic Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-1001-2020 — Clinical Diagnostic Solutions Clinical Diagnostic Solutions Hello, I own a Clinical Diagnostic Solutions that is covered by recall Z-1001-2020 from Clinical Diagnostic Solutions. 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.
