Ortho Clinical Diagnostics recalls VITROS Chemistry Products Calibrator Kit 32 due to potential unsuccessful calibration from software anomalies in the VITROS system. Affected units include specific product codes and assay data disks.
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 for use with their clinical chemistry analyzers. The recall is due to a software anomaly that could cause unsuccessful calibration, which might lead to inaccurate test results.
The software anomaly in the VITROS system could cause the calibrator kit to fail during calibration. This might result in inaccurate test results if the system is not properly calibrated, potentially affecting patient care.
Healthcare facilities using the VITROS clinical chemistry analyzer with the affected calibrator kit are most at risk. This includes labs and clinics that rely on the kit for accurate diagnostic testing.
Check for product code 6844508 on the calibrator kit. Affected units also include assay data disks with driver version 6032 or higher (DRV 6032 or above).
Verify the product code (68445:08) and driver version (DRV 6032 or higher) on the calibrator kit and associated assay data disks.
The recall states there is a software anomaly that could cause unsuccessful calibration, but does not specify the exact issue.
Check for product code 6844508 and driver version 6032 or higher (DRV 6032 or above) on the assay data disk.
The recall does not specify a stop-use action; the remedy is null, so users can continue using it but should check for the affected version.
We’ve drafted a message you can send Ortho Clinical Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2185-2019 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-2185-2019 from Ortho Clinical Diagnostics. 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.
