Beckman Coulter recalls UniCel DxH 800 analyzers with specific serial numbers due to sporadic platelet errors that could lead to unrecognized low platelet counts, potentially causing health risks.
Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized.
Beckman Coulter is recalling certain UniCel DxH 800 analyzers because they may give false high platelet counts without warning. This could lead to undetected low platelet levels (thrombocytopenia), which might cause serious health issues if not caught.
The analyzers may produce sporadic false high platelet results without any warning flags or system messages. This could lead to thrombocytopenia (low platelet count) going unrecognized, which might cause serious health complications if not addressed.
Clinical laboratory users who operate the UniCel DxH 800 analyzers with the listed serial numbers are most at risk. Patients receiving blood tests using these devices could potentially be affected.
Check the serial numbers on your UniCel DxH 800 analyzer: 629029, B24465, B24802, B68304, B66445, or B63322. These specific models are affected by the recall.
Identify if your UniCel DxH 800 analyzer has one of the listed serial numbers: 629029, B24465, B24802, B68304, B66445, or B63322.
Beckman Coulter is recalling these analyzers because they may produce sporadic false high platelet results without warning flags, which could lead to unrecognized thrombocytopenia.
Check the serial numbers on your UniCel DxH 800 analyzer. If it matches the listed numbers, contact Beckman Coulter for further instructions.
The recall indicates a potential risk of undetected low platelet counts (thrombocytopenia), which could lead to serious health issues if not addressed. However, the hazard is not described as causing immediate injury.
We’ve drafted a message you can send Beckman Coul: 1-2 words to request your refund or repair — edit it as you like.
Subject: Recall Z-1382-2019 — Beckman Coul: 1-2 words Beckman Coul: 1-2 words Hello, I own a Beckman Coul: 1-2 words that is covered by recall Z-1382-2019 from Beckman Coul: 1-2 words. 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.
