Ortho-Clinical recalls VITROS Prolactin Reagent Packs with low end imprecision causing false high results. Affected lots from May to October 2022. Stop using if you have these lots.
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 Prolactin Reagent Packs that may give falsely high or delayed test results. This could lead to incorrect medical diagnoses if used in patient testing. The affected lots are listed in the recall notice.
The reagent packs may produce false high or delayed results when testing samples at the low end of the measurable range. This happens due to calibration failures with Calibrator Level 1, which can affect both patient and quality control samples.
Lab users and healthcare providers who test with the affected VITROS Prolactin Reagent Packs. Those with the specific lot numbers listed in the recall are most at risk.
Check the lot number on the reagent pack. Affected lots include 2840 (May 13, 2022), 2850 (June 8, 2022), 2860 (July 2, 2022), 2870 (July 17, 2022), 2875 (July 17, 2022), 2880 (September 14, 2022), 2891 (September 28, 2022), and 2900 (October 29, 2022).
Look for the lot number on the reagent pack to see if it matches the affected lots listed in the recall.
The reagent packs may produce falsely high or delayed results for patient and quality control samples at the low end of the measurable range 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 further instructions.
The recall specifically covers VITROS Prolactin Reagent Packs with the listed lot numbers. Other products are not affected.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1114-2022 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1114-2022 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.
