Ortho-Clinical Diagnostics recalls VITROS Troponin I ES Reagent Packs that could produce false negative results due to incorrect wells. Affected lots were sold until June 2023.
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 Reagent Packs that might give false negative results. This could lead to incorrect health assessments if used in cardiac tests.
The reagent packs might have incorrect wells, causing the test to show a negative result when the patient actually has a heart condition. This could delay proper treatment.
Healthcare providers using these reagent packs for cardiac tests may be affected. Patients relying on these tests could be at risk of incorrect results.
Check for product code 6802301, UDI-DI 10758750002504, lot number 4800, or expiration date June 10, 2023. These packs were sold until the expiration date.
Verify the product code, UDI-DI, lot number, and expiration date to confirm if the pack is affected.
The reagent packs might produce false negative results, which could lead to incorrect health assessments if used in cardiac tests.
Check for product code 6802301, UDI-DI 10758750002504, lot number 4800, or expiration date June 10, 2023.
The recall does not require immediate stop use; check product details to confirm if affected.
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-2357-2023 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-2357-2023 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.
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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.
