Beckman Coulter recalls HmX CP and HmX AL Analyzers that may fail to detect blasts in some blood samples, requiring additional testing for certain diagnoses.
Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples.
Beckman Coulter is recalling HmX CP and HmX AL Hematology Analyzers because they might not flag certain blood abnormalities in rare cases. This could lead to missing critical diagnoses that require further testing.
The analyzers may not flag or detect blasts in some blood samples, which are critical for identifying certain blood disorders. This could lead to missing diagnoses that require additional testing.
Hematology lab users who operate these analyzers may be affected. Patients with blood conditions requiring precise diagnosis are at higher risk if the analyzer fails to detect abnormalities.
Check for the HmX CP or HmX AL analyzers with catalog numbers HMX CP - 178832, 178833, 178834, A91062, A90994 or HmX AutoLoader - 6605522, 6605523, 6605524. All software versions are included in this recall.
Identify if your analyzer has the catalog numbers listed in the recall notice.
Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary in rare situations where the analyzers may not flag or detect blasts in some blood samples.
The recall does not require immediate action; check if your analyzer has the listed catalog numbers and contact Beckman Coulter for further guidance.
The recall states this is a rare situation and does not indicate 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-3114-2017 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-3114-2017 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.
