Ortho-Clinical recalls VITROS Performance Verifier II units that may cause inaccurate lab results if used beyond 7 days after reconstitution.
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 II chemistry products due to potential QC drift when used with specific enzyme slides. This could lead to inaccurate test results, delayed patient results, or incorrect patient data if the QC results fall outside expected ranges.
The Performance Verifier II units may show QC drift when used with certain cholinesterase enzyme slides after 2-7 days of reconstitution. This can cause inaccurate test results, potentially leading to delayed patient results or incorrect patient data if the QC results fall outside expected ranges.
Lab technicians and healthcare facilities using VITROS 250/350/5,1 FS/4600/XT 3400 or VITROS 5600/XT 7600 chemistry systems. The risk is low for most users as the issue only affects specific product lots and requires precise handling conditions.
Check for the model number 8231474 on the VITROS Performance Verifier II units. The affected lots include W1667, X1901, A2114, D2338, and F2830 with specific expiration dates.
Identify the lot code on your VITROS Performance Verifier II unit to determine if it is affected (W1667, X1901, A2114, D2338, or F2830).
The recall occurs because certain lots of VITROS Performance Verifier II units may show QC drift when used with specific cholinesterase enzyme slides after 2-7 days of reconstitution, potentially causing inaccurate test results.
The official recall notice does not specify a remedy, so no action is required beyond checking if your product is in the affected lots.
Check the lot code on your VITROS Performance Verifier II unit; affected lots are W1667, X1901, A2114, D2338, and F2830 with specific expiration dates.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-2121-2025 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-2121-2025 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.
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.
