Beckman Coulter recalls UniCel DxH 600 hematology analyzers due to sporadic erroneous elevated platelet results, potentially leading to unrecognized thrombocytopenia. Affected units may require correction.
Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized.
Beckman Coulter is recalling UniCel DxH 600 hematology analyzers after complaints of sporadic erroneously elevated platelet results. This could lead to unrecognized thrombocytopenia, a condition where platelet counts are too low, risking bleeding complications.
The device occasionally shows falsely high platelet counts without warning flags or system messages. This can cause thrombocytopenia (low platelet count) to go undetected, increasing the risk of bleeding in patients.
Healthcare facilities and clinical laboratories that use the UniCel DxH 600 hematology analyzer for blood testing. Patients receiving blood tests with this device may be at risk of unrecognized low platelet counts.
The UniCel DxH 600 Coulter Cellular Analysis System with REF number B23858. This model is a benchtop unit without an instrument cart, computer stand, or connectivity capabilities. It is the same as the DxH 800 (K140911) but without the cart and connectivity features.
Look for the REF number B23858 on the UniCel DxH 600 hematology analyzer.
The device may show sporadic erroneous elevated platelet results, but it is not immediately dangerous. Users should monitor for warning signs and contact the manufacturer if issues arise.
The recall does not specify a remedy, so users should check with Beckman Coulter for guidance on potential corrections or updates.
The recall indicates a risk of unrecognized thrombocytopenia, which could lead to bleeding complications, but it does not specify a risk of serious injury in normal use.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1383-2019 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1383-2019 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.
