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.
FDA Recall Z-2031-2012 · Posted 2012-07-18
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Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeJTS
Date Initiated2012-04-12
Date Terminated2012-12-10
Product Quantity539 kits
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.
Firm Action
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
Distribution Pattern
Nationwide Distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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