PlainRecalls
FDA Devices Moderate Class II Terminated

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 cultures or specimens by the differential Gram method.

Reported: July 25, 2012 Initiated: April 12, 2012 #Z-2031-2012

Product Description

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 cultures or specimens by the differential Gram method.

Reason for Recall

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.

Details

Recalling Firm
Becton Dickinson & Co.
Units Affected
539 kits
Distribution
Nationwide Distribution.
Location
Sparks, MD

Frequently Asked Questions

What product was 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 cultures or specimens by the differential Gram method.. Recalled by Becton Dickinson & Co.. Units affected: 539 kits.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 25, 2012. Severity: Moderate. Recall number: Z-2031-2012.