ProductGuru
AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

[Recalled] VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest. — software automatically switches the lot when a vancomyc

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductVITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
Brand / manufacturerOrtho-Clinical Diagnostics
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2067-2012
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date21 May 2012

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment.

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

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.

Shop Recalled VITROS 4600 Chemistry
Search on Amazon ›Find on eBay ›
As an Amazon Associate and eBay Partner, we may earn from qualifying purchases.
Related articles

Explore by topic

Looking up a product? Use ProductGuru — free barcode & product database with 35M+ products. Search by EAN / UPC barcode.
Was this page helpful?