Ortho-Clinical Diagnostics recalls VITROS Chemistry Product Performance Verifier I 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 I devices because multiple coatings of AMYL Slides show imprecision in control fluid measurements. This could lead to inaccurate lab test results if used without correction.
The VITROS Chemistry Product Performance Verifier I may produce inconsistent control fluid measurements when compared to expected standards. This imprecision could lead to inaccurate amylase test results in laboratory settings.
Lab users who operate VITROS 250/350/5, 1 FS/4600/XT 3400, or VITROS 5600/XT 7600 chemistry systems may be affected. Those using the device for amylase testing are most at risk of inaccurate results.
Check for the Product Code 8231474 and UDI # 10758750004577 on the device. The device is used for in vitro diagnostic testing of amylase activity in serum, plasma, and urine.
Verify the Product Code 8231474 and UDI # 10758750004577 on the device to confirm it is affected.
Multiple coatings of AMYL Slides show imprecision on control fluids when compared to expected standards listed on the Performance Verifier Assay Sheets.
The imprecision could lead to inaccurate amylase test results in serum, plasma, and urine testing.
The recall does not specify a stop-use action; lab users should check device details and ensure accurate testing procedures.
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-2366-2020 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-2366-2020 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.
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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.
