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[Recalled] Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom; www.LeicaBiosystems.com; Bond Polymer

recall fda device united-kingdom

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductLeica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom; www.LeicaBiosystems.com; Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphate (A
Brand / manufacturerLeica Biosystems Newcastle Ltd.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0717-2014
Country of noticeUnited Kingdom
Risk levelClass II
Hazard typerecall
Notice date31 July 2013

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The affected lots of the product may contain a contaminant of fungus that can cause a loss of staining sensitivity and/or obstructions to fluid delivery to the slide.

This Class II recall concerns device products distributed in United Kingdom 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 →

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.

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