Ortho Clinical Diagnostics recalls VITROS Calibrator Kit 32 due to potential unsuccessful calibration from software anomalies. Affected units may need repair or replacement.
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 for use with V:ITROS 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 calibration to fail, resulting in inaccurate test results. This might affect the reliability of clinical chemistry tests performed by healthcare providers.
Healthcare facilities using the VITROS Calibrator Kit 32 for clinical testing are likely affected. Staff handling lab tests may be at risk if calibration fails.
Check for the product code 6844508 or UDI 10758750032105 on the calibrator kit. The kit is used with VITROS clinical chemistry analyzers.
Verify if the calibrator kit is functioning correctly by running a calibration test.
The recall is due to a software anomaly that could cause unsuccessful calibration, potentially leading to inaccurate test results.
The official recall notice does not specify a remedy or action steps beyond checking calibration status.
The recall addresses potential inaccurate test results, not direct injury risks.
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-2178-2019 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-2178-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
