Ortho-Clinical recalls VITROS Black Reference Slides (catalog J0231: 9252-0058-3361, 9252-0058-3362) due to incorrect labeling as White Reference Slides. Using these may cause delayed results for most tests.
Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as White Reference Slides. If the customer fails to notice both the product name or the unexpected color of the slides and tries to use Black Reference Slides as White Reference Slides, the Correction Factor test will fail - and the analyzer will not be able to produce results for any assays other than sodium, potassium, and chloride. If the customer doesnt have any White Reference Slides in reserve, they cant run the Correction Factor test correctly and get the analyzer running again until they get more White Reference Slides delivered. This could lead to a delay in results for all Vitros assays except for sodium, potassium, and chloride.
Ortho-Clinical is recalling two specific lots of VITROS Black Reference Slides because they are incorrectly labeled as White Reference Slides. If used as White slides, the analyzer won't produce results for most tests, causing delays until replacement slides are delivered.
The Black Reference Slides are incorrectly labeled as White Reference Slides. If a lab uses them as White slides, the analyzer won't run most tests correctly, causing delays until they get more White Reference Slides.
Lab users who have the recalled lots of VITROS Black Reference Slides (catalog J02316) may experience delays in test results if they use the slides incorrectly. Labs with no White Reference Slides in reserve are most at risk of extended delays.
Check for the catalog number J02316 on the slides. The affected lots are 9252-0058-3361 and 9252-0058-3362. These slides are used in the VITROS analyzer for correction factor adjustments.
Verify if the slides are labeled as Black or White. If labeled Black but used as White, they are affected.
Ortho-Clinical confirmed two lots of VITROS Black Reference Slides are incorrectly labeled as White Reference Slides, causing test delays if used incorrectly.
The analyzer won't produce results for most tests, only sodium, potassium, and chloride. Labs without White Reference Slides may face delays until replacements are delivered.
Check for catalog number J02316 and lots 9252-0058-3361 or 9252-0058-3362. These slides are used in VITROS analyzers for correction factor adjustments.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1489-2021 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1489-2021 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.
