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.
This recall has been terminated (originally issued July 18, 2012).
- Recall Initiated
- April 12, 2012
- Posted
- July 18, 2012
- Terminated
- December 10, 2012
- Recall Number
- Z-2031-2012
- Quantity
- 539 kits
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution.
Lot / Code Info
Lot 1348873, Exp April 30, 2013
Root Cause
Material/Component Contamination
Action Taken
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.