Ortho Clinical Diagnostics recalls VITROS : 5,1 FS Chemistry System due to potential unsuccessful calibration from software anomalies in version 3.1 or above. Affected units may need software update.
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Ortho Clinical Diagnostics is recalling its VITROS 5,1 FS Chemistry System clinical analyzers because software anomalies in version 3.1 or higher could cause calibration failures. This means test results might be inaccurate, which could affect medical diagnoses.
The software anomaly in version 3.1 or higher may cause calibration failures, leading to inaccurate test results. This could impact medical diagnoses if the equipment is used for critical tests.
Healthcare facilities using the VITROS 5,1 FS Chemistry System with software version 3.1 or higher are most at risk. Patients relying on inaccurate test results from this equipment could be affected.
Check if your VITROS 5,1 FS Chemistry System has software version 3.1 or higher. The product code is 6801375 and UDI is 10758750001132.
Verify your VITROS system's software version to see if it is 3.1 or higher.
No, this recall applies only to healthcare facilities using the VITROS 5,1 FS Chemistry System.
Check the software version on your VITROS 5,1 FS Chemistry System; affected units have software version 3.1 or higher.
The recall does not specify a remedy, so contact Ortho Clinical Diagnostics for guidance.
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-2183-2019 — Ortho Clinical Diagnostics Ortho Clinical Diagnostics Hello, I own a Ortho Clinical Diagnostics that is covered by recall Z-2183-2019 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.
