Ortho-Clinical Diagnostics recalls VITROS Troponin I ES Calibrators that may produce false negative results due to incorrect wells. Affected units have specific product codes and expiration dates.
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
Ortho-Clinical Diagnostics is recalling VITROS Troponin I ES Calibrators that could give false negative results if the reagent packs have incorrect wells. This could lead to inaccurate test outcomes, especially in critical cardiac tests.
The reagent packs might have incorrect wells, causing the tests to show false negative results. This means the test might indicate a normal result when the patient actually has a heart condition, potentially delaying treatment.
Healthcare professionals using these calibrators for cardiac tests may be affected. Patients relying on accurate troponin I tests could be at risk of incorrect results.
Check for product code 6802302, UDI-DI 10758750002511, lot number 4800, or expiration date before June 10, 2023.
Verify the product code, UDI-DI, lot number, and expiration date to confirm if your calibrator is affected.
The reagent packs may contain incorrect wells, which can cause false negative results in troponin I tests.
Check the product code, UDI-DI, lot number, and expiration date to see if it's affected. If so, contact Ortho-Clinical Diagnostics for guidance.
This recall does not involve a risk of serious injury; it's about potential false negative test results.
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-2358-2023 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-2358-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
