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[Recalled] BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms from cul

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

ProductBD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
Brand / manufacturerBecton Dickinson & Co.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2031-2012
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date12 April 2012

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci.

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 Becton Dickinson & Co.

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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