Ortho-Clinical Diagnostics recalls VITROS Chemistry Product Performance Verifier II (Product Code 8067324) due to imprecise control fluid measurements affecting lab test accuracy. Affected units may show inconsistent results with expected standards.
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Performance Verifier II units because they may produce inaccurate test results for amylase activity measurements. This could lead to incorrect lab diagnoses if the device is used without proper calibration.
The device may show imprecision in control fluid measurements compared to expected standards. This could cause lab results to be inconsistent, potentially leading to incorrect diagnoses if the device is not properly calibrated.
Lab technicians and healthcare facilities using the VITROS Chemistry Product Performance Verifier II for amylase testing may be affected. Those handling the device in clinical settings are most at risk of inaccurate test results.
Check for the Product Code 8067324 on the device. The recall applies to units sold with UDI # 10758750004317 for in vitro diagnostic use in amylase testing.
Identify the Product Code 8067324 and UDI # 10758750004317 on the device to confirm if it is affected.
The device may show imprecision in control fluid measurements compared to expected standards, potentially causing inaccurate amylase test results.
Check the Product Code 8067324 and UDI # 10758750004317 to confirm if it is affected. No specific remedy is stated in the recall notice.
The recall does not mention any risk of injury; it addresses potential inaccuracies in lab test results.
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-2367-2020 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-2367-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
