Horiba recalls clinical chemistry analyzers that may report false high lipase results due to triglyceride interference. Affected models include ABX Pentra Lipase CP and ABX Pentra 400/Pentrac400. Check your model number and software version for recall details.
Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Cholesterol CP. An over estimation of the lipase concentration could be observed and a patient result could be declared abnormal by the instrument due to these interferences instead of normal result < 38 U/L (or < reference value used in your laboratory).
Horiba is recalling certain clinical chemistry analyzers that may report false high lipase results due to triglyceride interference. This could lead to incorrect patient results being flagged as abnormal when they are actually normal. The recall affects all units with model number 1220001631 and software versions from the specified lot.
The analyzer may incorrectly report high lipase levels due to triglyceride interference, causing it to flag results as abnormal when they are actually normal. This could lead to unnecessary patient concern or additional testing if the results are not properly interpreted by lab staff.
Healthcare facilities using Horiba clinical chemistry analyzers with model number 1220001631 and software versions from the affected lots are most at risk. Patients receiving lab tests on these analyzers may see false abnormal results.
Check your analyzer's model number and software version. Affected units have model number 1220001631 and were sold with the specified lot numbers and software versions.
Verify your analyzer's model number is 1220001631.
Ensure your software version matches the affected lots listed in the recall notice.
The analyzer may report false high lipase results due to triglyceride interference, causing it to flag results as abnormal when they are actually normal.
Check your model number and software version. If it matches the affected units, contact Horiba for further instructions.
The recall addresses potential false results, not direct harm to patients. However, incorrect results could lead to unnecessary testing or patient concern.
We’ve drafted a message you can send Horiba to request your refund or repair — edit it as you like.
Subject: Recall Z-0119-2020 — Horiba Horiba Hello, I own a Horiba that is covered by recall Z-0119-2020 from Horiba. 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.
