Ortho-Clinical recalls VITROS Chemistry Diluent Pack 3 (Lot 01-1645) that may cause inaccurate test results when used with CRP Slides. Affected units include specific model and lot numbers.
VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.
Ortho-Clinical is recalling VITROS Chemistry Products FS Diluent Pack 3, Model 6801754, Lot 01-1645. This diluent may cause test results to be inaccurate when used with CRP Slides, potentially leading to incorrect medical diagnoses.
The recalled diluent pack may cause test results to be negatively biased when used with CRP Slides. This means test results could be too low, potentially leading to incorrect medical decisions.
Patients using VITROS Chemistry CRP Slides with the recalled diluent pack may get inaccurate test results. Healthcare facilities that use this specific diluent pack for testing are most at risk.
Check for the model number 6801754 and lot number 01-1645 on the diluent pack. The product comes with 3 packs per sales unit and expires on July 5, 2024.
Look for model number 6801754 and lot number 01-1645 on the diluent pack.
Using the recalled diluent pack may cause test results to be negatively biased when used with CRP Slides, potentially leading to inaccurate medical diagnoses.
Check for model number 6801754 and lot number 01-1645 on the diluent pack. The product comes with 3 packs per sales unit and expires on July 5, 2024.
The recall record does not specify a remedy, so contact Ortho-Clinical for guidance.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-2266-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-2266-2024 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.
