Recall Z-2031-2012
Becton Dickinson & Co. · initiated April 12, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot 1348873, Exp April 30, 2013
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.
FDA-determined 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.
Details
- Recall number
- Z-2031-2012
- Initiated
- April 12, 2012
- Posted by FDA
- July 18, 2012
- Terminated
- December 10, 2012
- Product code
- JTS – Stains, Microbiologic
- Quantity
- 539 kits
- Distribution
- Nationwide Distribution.
- Recalling firm
- Becton Dickinson & Co., Sparks, MD
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2032-2012 Class II | Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gram Stain Kits…Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small &… | 04/12/2012Terminated |