Ortho-Clinical recalls VITROS Calibrator Kit 11 VANC Reagent Generation 50 with affected Assay Data Disk for delayed testing results. Fix by updating to newer software versions.
Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing
Ortho-Clinical is recalling VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation 50 with affected Assay Data Disk (ADD) for Data Release Versions 6215 through 6223. This causes delays in vancomycin testing results, which could impact patient care.
The affected Assay Data Disk (ADD) causes delays in calibrating vancomycin tests. This means test results for vancomycin levels may be delayed, potentially affecting treatment decisions for patients receiving this antibiotic.
Healthcare facilities using VITROS 5,1 FS/4600 or VITROS 5600/XT 7600 systems with the affected calibrator kit and assay data disk. Patients receiving vancomycin treatments may experience delayed test results.
Check if your VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 has an Assay Data Disk (ADD) with Data Release Versions (DRVs) 6215 through 6223. Product code 6801696 and lot number 1172 are associated with this recall.
Verify your VITROS system's software version matches the Data Release Version (DRV) of the Assay Data Disk. If it's 6215-6223, it's affected.
Contact Ortho-Clinical to update to a newer Data Release Version (DRV) that resolves the calibration delay issue.
The affected Assay Data Disk (ADD) causes delays in calibrating vancomycin tests, which could impact patient care by delaying treatment decisions.
Check your VITROS system's software version. If it's Data Release Versions 6215-6223, contact Ortho-Clinical to update to a newer version.
No, this recall is for delayed testing results, not a physical hazard. The danger level is low risk.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1664-2023 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1664-2023 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.
