Ortho-Clinical recalls VITROS Performance Verifier I models with potential inaccurate QC results due to quality control drift when used with specific enzyme slides. Affected lots may cause delayed patient results or erroneous test results.
Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
Ortho-Clinical is recalling VITROS Performance Verifier I models that may produce inaccurate quality control results when used with certain enzyme slides. This could lead to delayed patient results or incorrect test outcomes if the device is used after the recommended reconstitution period.
The device may show QC drift when used 2-7 days after reconstitution with certain enzyme slides, leading to inaccurate results. This can cause delayed patient results or incorrect test outcomes if the device is used outside the label's 7-day stability claim.
Healthcare facilities using VITROS Performance Verifier I models with specific lots of enzyme slides. Users most at risk are those who rely on the device for critical patient testing without proper QC monitoring.
Check for model number 806 7324 on the VITROS Performance Verifier I. Affected lots include V1665 (exp. 8/14/2025), B2245 (exp. 3/25/2026), Y2110 (exp. 3/25/2026), and E2828 (exp. 2/3/2027).
Look for the lot code on the VITROS Performance Verifier I, which may be V1665, B2245, Y2110, or E2828.
Using the device with certain enzyme slides after reconstitution may cause inaccurate QC results, leading to delayed patient results or incorrect test outcomes.
Check the lot code on the device; affected lots include V1665 (exp. 8/14/2025), B2245 (exp. 3/25/2026), Y2110 (exp. 3/25/2026), and E2828 (exp. 2/3/2027).
No, but you should check the lot code to ensure you are not using an affected model. The device can still be used safely if the lot is not affected.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-2120-2025 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-2120-2025 from Ortho-Clinical. 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.
