Ortho-Clinical recalls VITROS iPTH reagent packs with negative bias in test results. Affected lots may cause inaccurate parathyroid hormone measurements. Contact for remedy details.
Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results
Ortho-Clinical is recalling VITROS iPTH reagent packs that may produce test results 12% lower than actual patient levels. This could lead to incorrect diagnoses if used in medical testing.
The reagent packs may produce test results that are 12% lower than the true patient levels. This negative bias could lead to incorrect diagnoses if the tests are used for medical decisions.
Healthcare providers using the VITROS iPTH reagent packs for parathyroid hormone testing are likely affected. Patients receiving tests using these reagents may be at risk of inaccurate results.
Check the lot numbers on the reagent pack: 1610, 1621, 1630, 1640, 1645, 1650, or 1670. These were sold with specific expiration dates starting from April 2023.
Look for lot numbers 1610, 1621, 1630, 1640, 1645, 1650, or 1670 on the reagent pack.
The reagent packs may produce test results 12% lower than actual patient levels, leading to potential incorrect diagnoses.
The recall record does not specify a remedy, so contact Ortho-Clinical for guidance.
Yes, the reagent packs with lot numbers listed were sold with expiration dates starting from April 2023.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-0878-2023 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-0878-2023 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.
