Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gram Stain Kits and Reagents are used to stain mic
FDA device recall Z-2032-2012 · posted 2012-07-18 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- 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.
- 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.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- JTS
- Quantity affected
- 878 cartons/ 3512 bottles
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-04-12
- Date posted
- 2012-07-18
- Date terminated
- 2012-12-10
- Location
- Sparks, MD
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