Ortho-Clinical Diagnostics recalls VITROS PHYT Slides (Catalog 8298671) due to potential imprecise test results. Affected lots may cause inaccurate quality control and patient samples.
There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples.
Ortho-Clinical Diagnostics is recalling VITROS PHYT Slides with catalog number 8298671 because they can produce imprecise test results. This affects both quality control samples and patient tests, potentially leading to incorrect health assessments.
The slides have a coating version 0165 that can cause test results to be higher or lower than expected. This imprecision affects both quality control samples and patient samples, potentially leading to incorrect health assessments.
Lab users and healthcare professionals who have the specific VITROS PHYT Slides with catalog number 8298671 and affected lot numbers are most at risk. Patients using these slides for testing may receive inaccurate results.
Check for the catalog number 8298671 on the slides. Affected lots include specific numbers like 2616-0165-4866 through 2616-0165-7226. These slides are used in in vitro diagnostic testing.
Look for the lot number on the slide packaging or label to determine if it's affected.
Ortho-Clinical Diagnostics recalls VITROS PHYT Slides with catalog number 8298671 due to potential imprecise results when using coating version 0165.
Using affected slides may cause test results to be higher or lower than expected for both quality control and patient samples.
Check the lot number on the slide packaging or label. Affected lots include specific numbers listed in the recall notice.
We’ve drafted a message you can send Ortho-Clinical Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2344-2018 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-2344-2018 from Ortho-Clinical Diagnostics. 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.
