Ortho Clinical Diagnostics recalls VITROS 25:0AT chemistry analyzers with software version 9.7 due to potential calibration failures. Affected units may not provide accurate test results.
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Ortho Clinical Diagnostics is recalling VITROS 250AT chemistry analyzers that may have software version 9.7. This could lead to inaccurate test results if the system is not properly calibrated.
The software anomaly in version 9.7 may cause the system to fail calibration, leading to inaccurate test results. This could affect the reliability of clinical tests and potentially impact patient care.
Healthcare facilities using the VITROS 250AT chemistry analyzers with software version 9.7 are affected. Laboratory staff and patients using these analyzers for clinical testing are at risk of inaccurate results.
Check if your VITROS 250AT chemistry analyzer has software version 9.7. The product code is 1758143 and UDI is 10758750000036.
Verify your VITROS 250AT analyzer's software version; affected units have version 9.7.
The recall is due to a potential software anomaly in version 9.7 that may cause unsuccessful calibration, leading to inaccurate test results.
Check if your analyzer has software version 9.7, product code 1758143, or UDI 10758750000036.
The recall does not specify a remedy, so contact Ortho Clinical Diagnostics for further instructions.
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-2176-2019 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-2176-2019 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.
