FDA Enforcement
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.
Recall: Z-2031-2012
·
Reported July 25, 2012
Enforcement
- Recall Number
- Z-2031-2012
- Event ID
- 61769
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Becton Dickinson & Co.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 25, 2012
- Initiation Date
- April 12, 2012
- Classification Date
- July 18, 2012
- Termination Date
- December 10, 2012
- Address
- BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States
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
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.
Code Info
Lot 1348873, Exp April 30, 2013
Distribution
Nationwide Distribution.
Quantity
539 kits