Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. 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-2032-2012
- Quantity
- 878 cartons/ 3512 bottles
- 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
Lots 1325324 Exp May 31,2013 and 2011746, Exp July 31,2013
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.