BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized)
FDA device recall Z-2031-2012 · 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
- 539 kits
- 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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