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
- Recall Number
- Z-2031-2012
- Event Number
- 61769
- Firm
- Becton Dickinson & Co. BD Diagnostic Systems
- FEI Number
- 1119779
- Product Code
- JTS
- Status
- Terminated
- Root Cause
- Material/Component Contamination
- Initiated
- April 12, 2012
- Posted
- July 18, 2012
- Terminated
- December 10, 2012
- Address
- 7 Loveton Circle, Sparks, MD, 21152-0999
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.
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.
BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter dated April 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use and discard the affected product. An Acknowledgement Form was attached for customers to complete and return via fax to 410-316-4258. Contact the BD Customer Service Department for questions regarding this recall.
Nationwide Distribution.
539 kits