Ortho-Clinical Diagnostics recalls VITROS VALP Reagent Pack (catalog #6801710) due to negative bias results in valproic acid testing. Affected lots from 2017-2019 may cause inaccurate test results.
Negative bias results when using VITROS VALP Reagent, GEN 25.
Ortho-Clinical Diagnostics is recalling VITROS VALP Reagent Packs (catalog #6801710) that can produce negative bias results when used in valproic acid testing. This means tests might show lower levels of valproic acid than actually present, potentially leading to incorrect medical decisions.
The VITROS VALP Reagent Pack can produce negative bias results when used in valproic acid testing. This means the test might show lower valproic acid levels than actually present, potentially leading to incorrect medical decisions if the test results are relied upon.
Healthcare providers using VITROS 5,1 FS, 4600, or 5600 chemistry systems with the affected reagent packs (catalog #6801710) are likely affected. Patients receiving valproic acid tests using these reagents may be at risk of inaccurate results.
Check for the catalog number 6801710 on the reagent pack. Affected lots include 25-5263 (expired 2017-09-09), 25-5503 (expired 2018-01-06), 25-5727 (expired 2018-04-30), 25-5974 (expired 2018-08-14), 25-6067 (expired 2018-11-05), and 25-6393 (expired 2019-04-05).
Look for the lot number on the reagent pack to see if it matches the affected lots listed: 25-5263, 25-5503, 25-5727, 25-5974, 25-6067, or 25-6393.
The reagent pack can produce negative bias results when used in valproic acid testing, meaning tests might show lower levels of valproic acid than actually present.
Affected lots include 25-5263 (expired 2017-09-09), 25-5503 (expired 2018-01-06), 25-5727 (expired 2018-04-30), 25-5974 (expired 2018-08-14), 25-6067 (expired 2018-11-05), and 25-6393 (expired 2019-04-05).
No action is required for the reagent pack if it is not one of the affected lots. Check the lot number to confirm if it is 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-0848-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-0848-2019 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.
