Ortho-Clinical recalls VITROS CHE Slides (catalogs 191 4605 and 800 4707) due to potential inaccurate test results from QC drift when used 2-7 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 Chemistry Products CHE Slides with specific catalog numbers because using them too long after reconstitution can cause inaccurate test results. This may lead to delayed patient results or incorrect patient outcomes if quality control tests show results outside expected ranges.
The slides can develop QC drift when paired with specific Performance Verifiers (PVs) after 2-7 days of reconstitution. This drift may cause test results to be inaccurate, potentially leading to delayed patient results or incorrect patient outcomes if quality control tests fall outside expected ranges.
Laboratory users who handle VITROS CHE Slides with catalog numbers 191 4605 (300 slides) or 800 4707 (90 slides) are affected. Those who use the slides beyond 7 days after reconstitution are at higher risk of inaccurate test results.
Check for catalog numbers 191 4605 (300 slides) or 800 4707 (90 slides) on the slides. The product was sold with all lots within expiry dates.
Verify the catalog number on the slides to confirm if they are affected (191 4605 or 800 4707).
The slides can develop QC drift when used with specific Performance Verifiers after 2-7 days of reconstitution, potentially causing inaccurate test results.
Using the slides beyond 7 days after reconstitution with specific Performance Verifiers may cause inaccurate test results, leading to delayed patient results or incorrect patient outcomes.
Look for catalog numbers 191 4605 (300 slides) or 800 4707 (90 slides) on the slides. The product was sold with all lots within expiry 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-2122-2025 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-2122-2025 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.
