Ortho-Clinical recalls VITROS Calibrator Kit 29- In-Vitor with incorrect expiration date (24-Jul-2024) that may cause inaccurate test results if not updated with Assay Data Disk.
Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its true expiration and the customer does not have their Assay Data Disk (ADD) updated, the system will allow them to use the expired calibrator which may bias the results. However, at this time the calibrator is within its use date and will function appropriately.
Ortho-Clinical is recalling VITROS Chemistry Products Calibrator Kit 29- In-Vitor due to an incorrect expiration date. Using this kit past its true expiration without updating the Assay Data Disk may cause inaccurate test results. The kit is currently within its use date and functions properly.
The calibrator kit has an incorrect expiration date (24-Jul-2024) instead of the extended date (24-Jul-2025) that was assigned. If used past its true expiration without updating the Assay Data Disk, the system may show inaccurate test results.
Laboratories using the VITROS 5,1 FS/4600 or VITROS 5600/XT 7600 systems with the specific calibrator kit lot 2953 are affected. Those who use the kit without updating the Assay Data Disk after expiration may get inaccurate test results.
Check for the calibrator kit model 29- In-Vitor with lot number 2953 and expiration date 24-Jul-2024. It's used with VITROS 5,1 FS/4600 and VITROS 5600/XT 7600 systems for iron-binding capacity testing.
Update the Assay Data Disk if the calibrator kit has expired to prevent inaccurate test results.
Yes, the kit is within its use date and functions properly as long as it's not used past its true expiration without updating the Assay Data Disk.
The system may show inaccurate test results, which could affect the accuracy of iron-binding capacity measurements.
Look for the calibrator kit model 29- In-Vitor with lot number 2953 and expiration date 24-Jul-2024 used with VITROS 5,1 FS/4600 or VITROS 5600/XT 7600 systems.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-2245-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-2245-2024 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.
