Ortho-Clinical recalls VITROS CHE Slides (Japan) with catalog numbers 684 4074 and 684 4138 due to potential QC drift causing inaccurate test results. Affected units may need repeat testing or patient results could be erroneous.
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 (Japan) with specific catalog numbers because using certain lots of these slides with Performance Verifiers can cause inaccurate quality control results. This may lead to delayed patient results or incorrect test outcomes if the QC results fall outside expected ranges.
The slides can develop quality control drift when used with specific Performance Verifiers after 2-7 days of reconstitution. This drift may cause QC results to fall outside expected ranges, leading to repeated testing or erroneous patient results with a small positive bias.
Laboratories using Ortho-Clinical VITROS CHE Slides with catalog numbers 684 4074 (90 slides) or 684 4138 (300 slides) in Japan are most at risk. Patients may experience delayed results or inaccurate test outcomes if the quality control process fails.
Check for catalog numbers 684 4074 (90 slides) or 684 4138 (300 slides) on the VITROS CHE Slides (Japan) product. The recall applies to all lots within the product's expiration date.
Identify if your VITROS CHE Slides have catalog numbers 684 4074 (90 slides) or 684 4138 (300 slides).
The recall is due to potential quality control drift when certain lots of Performance Verifiers are used with specific lots of CHE slides after reconstitution, which may cause inaccurate test results.
If QC results fall outside the customer's established ranges, it could lead to delayed patient results due to repeated testing or reconstitution of new Performance Verifiers.
The recall record does not specify a remedy; the manufacturer has not provided instructions for fixing the problem.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-2123-2025 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-2123-2025 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.
