Ortho-Clinical recalls VITROS Chemistry Calibrator Kit 9 (GEN 22) due to calibration errors causing delayed test results. Affected units include specific slide generations and lots.
Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The erroneous mathematics on the calibration disk prevents the VITROS 250/350 Chemistry System from successfully calibrating, leading to delayed results.
Ortho-Clinical is recalling VITROS Chemistry Calibrator Kit 9 (GEN 22) because faulty calibration math prevents proper testing, leading to delayed results. This affects lab equipment used for in vitro diagnostics.
The calibration disk contains incorrect math that prevents the VITROS system from properly calibrating the slides. This causes test results to be delayed, which could impact timely patient care but does not cause injury.
Lab users with VITROS 250/350/5,1 FS/4600/XT 3400 or VITROS 5600/XT 7600 systems using the specific calibrator kit and slides. Most at risk are healthcare facilities that rely on these diagnostic tests.
Check for VITROS Chemistry Calibrator Kit 9 (GEN 22) with slide generation 22. Product lots include 0911 (May 2023), 0921 (Oct 2023), 0942 (Jun 2024), 0980 (Oct 2022), and 0991 (Mar 2023).
Verify if your VITROS Calibrator Kit 9 is labeled GEN 22 with the specific lots listed in the recall notice.
The calibration disk contains incorrect math that prevents the VITROS system from properly calibrating the slides, causing delayed test results.
No, the recall does not require immediate discontinuation. Affected units should be checked for the specific lots and generation.
Check the product details against the listed lots and generation. If affected, contact Ortho-Clinical for further instructions.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-0220-2023 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-0220-2023 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.
