Ortho-Clinical Diagnostics recalls VITROS Performance Verifier I devices with mismatched diluent lots that may cause incorrect test results, leading to potential patient safety risks.
The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.
Ortho-Clinical Diagnostics is recalling VITROS Performance Verifier I devices that may have mismatched diluent lots. This could cause incorrect test results for sodium and carbon dioxide, potentially delaying care or causing inaccurate patient outcomes.
The device uses mismatched diluent lots that can cause positive or negative bias in sodium and carbon dioxide testing. This may lead to incorrect test results, potentially causing delays in patient care or inaccurate diagnoses.
Healthcare facilities using the VITROS Performance Verifier I device are likely affected. Patients receiving tests from these devices may be at risk of inaccurate results.
Check for the product code 8067324, GTIN 10758750004317, or lot number Q1174 on the device. The recall applies to devices sold with these specific identifiers.
Look for the product code 8067324, GTIN 10758750004317, or lot number Q1174 on the device.
The device may have mismatched diluent lots that cause positive or negative bias in sodium and carbon dioxide testing, leading to potential incorrect results.
Incorrect test results could lead to testing delays or inaccurate patient outcomes, potentially impacting treatment decisions.
The recall record does not specify a remedy, so facilities should check device details and contact Ortho-Clinical Diagnostics for guidance.
We’ve drafted a message you can send Ortho-Clinical Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-1372-2024 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-1372-2024 from Ortho-Clinical Diagnostics. 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.
