Ortho-Clinical Diagnostics recalls VITROS Performance Verifier II devices due to risk of incorrect test results for sodium and carbon dioxide. Affected units may cause patient testing delays or inaccurate results.
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 II devices because mismatched diluent lots can cause incorrect test results for sodium and carbon dioxide. This could lead to testing delays or inaccurate patient results if the device is used without proper calibration.
The device uses mismatched diluent lots that can cause negative bias in sodium and carbon dioxide testing. This means test results may be too low, potentially leading to incorrect patient diagnoses or treatment decisions.
Healthcare facilities using the VITROS Performance Verifier II device for clinical testing are most at risk. Patients receiving tests from affected devices may experience inaccurate results.
Check for the product code 8231474, GTIN 1075:8750004577, or lot number R1176 on the device. The recall applies to devices sold with these specific identifiers.
Verify the product code, GTIN, or lot number on your VITROS Performance Verifier II device to confirm if it is affected.
The device may produce test results that are too low for sodium and carbon dioxide, potentially causing testing delays or inaccurate patient results.
Check for product code 8231474, GTIN 10758750004577, or lot number R1176 on the device.
The recall does not specify a remedy, so no action is required beyond checking if your device is affected.
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-1373-2024 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-1373-2024 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.
