Beckman Coulter recalls UniCel DxH 900 hematology analyzers due to sporadic platelet result errors that could cause undiagnosed thrombocytopenia. Affected units may need calibration or software updates.
Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized.
Beckman Coulter is recalling UniCel DxH 900 hematology analyzers after complaints of sporadic platelet result errors. This could lead to undiagnosed thrombocytopenia, a condition where platelet counts are too low, increasing bleeding risk.
The device occasionally reports falsely high platelet counts without warning. This could cause thrombocytopenia (low platelet count) to go undetected, increasing the risk of uncontrolled bleeding.
Clinical laboratory users who operate the UniCel DxH 900 hematology analyzers are most at risk. Patients whose blood tests are affected by the device may not receive accurate platelet counts.
The UniCel DxH 900 hematology analyzer with REF number C11478. This device is used in clinical laboratories for blood testing and is part of the DxH 800 instrument family.
Look for the REF number C11478 on the device or its documentation.
Complaints received of sporadic erroneously elevated platelet results without flags or system messages, which could lead to undiagnosed thrombocytopenia.
If you use this device in your lab, it may report falsely high platelet counts, potentially causing undiagnosed thrombocytopenia.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1384-2019 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1384-2019 from Beckman Coulter. 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.
