[Recalled] Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The CM/RT incubator processes Microslide reagents with the following VITROS systems: 1) VITROS 5,

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: Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement.

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

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• VITROS 5,1 FS Chemistry System, Software Version 2.8 & Below Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. VITROS Urine Assays: VITROS Calcium (Ca), Magnesium (Mg), and Phosphorus (Phos) requires acidification pretreatment prior to urine assa — Class II
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• VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431 VITROS PROT Slides quantitatively measure protein (PROT) concentration in cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. — Class II
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• VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445. Intended for use in the measurement of a variety of chemistry analytes. — 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.