Ortho-Clinical recalls VITROS LH Reagent Packs (lot 1910-1960) due to potential false high or delayed test results. Affected units may cause inaccurate patient and QC results.
Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.
Ortho-Clinical is recalling VITROS LH Reagent Packs that could give false high or delayed test results. This might lead to incorrect patient diagnoses if used without replacement.
The reagent has low end imprecision, meaning it may not measure low levels of hormones accurately. This can cause false high or delayed results in patient tests and quality control checks, especially with Calibrator Level 1.
Lab users who test with VITROS LH Reagent Packs (product code 1350198) from August 2022 to January 2023 are affected. Patients using these reagents for hormone tests may see inaccurate results.
Check for product code 1350198 on the reagent pack. Affected lots were sold from August 2022 through January 2023 with expiration dates listed as 1910-1960.
Look for the lot number on the reagent pack to see if it matches the affected lots (1910-1960).
The reagent has low end imprecision, which can cause false high or delayed test results for patient and QC samples, especially at low hormone levels.
Check the lot number on the reagent pack to see if it matches the affected lots (1910-1960). If it does, contact Ortho-Clinical for guidance.
This recall is for potential inaccurate test results, not immediate safety risks. The hazard is low risk as it affects test accuracy rather than causing injury.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1113-2022 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1113-2022 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.
