[Recalled] VITROS 250AT Chemistry System, clinical chemistry analyzer — Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | FDA 2019-07-08

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Ortho Clinical Diagnostics

• VITROS 5600 Integrated System, clinical chemistry analyzer — Class II
• VITROS XT7600 Integrated System, Product code 6844461 — Class II
• VITROS 250 Chemistry System, clinical chemistry analyzer — Class II
• VITROS XT3400 Chemistry System, Product code 6844458 — Class II
• VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979 — Class II
• VITROS 250 Chemistry System, clinical chemistry analyzer — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.