Ortho Clinical Diagnostics recalls VITROS 250 Chemistry System due to potential unsuccessful calibration from software anomaly in version 9.7. Affected units may need software update.
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Ortho Clinical Diagnostics is recalling its VITROS 250 Chemistry System because a software issue in version 9.7 could lead to calibration failures. This means lab tests might not be accurate, which could affect medical results.
The software anomaly in version 9.7 could cause the device to fail calibration, meaning test results might be inaccurate. This could lead to incorrect medical diagnoses if the device is used for critical tests.
Lab users who own the VITROS 250 Chemistry System with software version 9.7 are most at risk. This affects medical testing facilities that use the device.
Check if your VITROS 250 Chemistry System has software version 9.7. The product code is 6801759 (refurbished) and UDI is 10758750001330.
Verify your VITROS 250 system's software version to see if it is 9.7.
The recall is for software version 9.7, which could cause calibration errors. If your system has this version, test results might be inaccurate.
Check for software version 9.7. The product code is 6801759 (refurbished) and UDI is 10758750001330.
The recall does not specify a remedy, so contact Ortho Clinical Diagnostics for guidance on updating the software.
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-2175-2019 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-2175-2019 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.
