Ortho-Clinical Diagnostics recalls VITROS Chemistry BuBc Slides due to etrombopag interference. Affected products measure bilirubin; check UDI codes for details.
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
Ortho-Clin: Diagnostics is recalling VITROS Chemistry BuBc Slides because they can give inaccurate bilirubin test results when used with etrombopag. This could lead to incorrect health assessments if the slides are used without proper testing procedures.
The slides can produce false bilirubin readings when etrombopag (a medication) is present in the sample. This interference may cause incorrect test results, but it does not cause immediate harm or injury.
Healthcare providers using these slides for bilirubin testing in labs are affected. Patients receiving tests using these slides may be at risk of inaccurate results.
Check for product codes 8383051 (60 slides) or 1612365 (18 slides). The unique device identifier (UDI) numbers 10758750004829 and 10758750009398 are associated with these products.
Identify if your slides have product codes 8383051 (60 slides) or 1612365 (18 slides).
The slides can give inaccurate bilirubin test results when etrombopag is present in the sample, which may lead to incorrect health assessments.
Check the product codes and UDI numbers to confirm if your slides are affected; no specific action is required beyond verification.
The recall is for potential inaccurate test results, not immediate safety risks. No injuries have been reported.
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-2874-2020 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-2874-2020 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.
