Ortho-Clinical recalls VITROS FSH Reagent Packs with low end imprecision causing false high or delayed results. Affected lots from March 2022 to September 2022. Check your lot numbers for recall.
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 FSH Reagent Packs that may give false high or delayed test results at low levels. This could lead to incorrect medical diagnoses if used without correction.
The reagents may produce false high or delayed results at low levels. This happens because of calibration failures with Calibrator Level 1, which affects low-level quality control and patient samples.
Lab users who test with these reagents may have inaccurate results. Patients relying on these tests for fertility or hormone levels could be affected if the lab uses the recalled reagents.
Check the lot number on the reagent pack. Affected lots were sold from March 2022 to September 2022 with specific expiration dates listed in the recall notice.
Look for the lot number on the VITROS FSH Reagent Pack. Affected lots include specific dates from March 2022 to September 2022.
The reagents may produce false high or delayed results at low levels due to calibration failures with Calibrator Level 1.
Check the lot number on the reagent pack. If it matches the affected lots listed in the recall, stop using it and contact Ortho-Clinical for instructions.
The recall addresses potential inaccurate test results, not direct safety risks. This is a low-risk issue for lab users.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1112-2022 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1112-2022 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.
