Enforcement Report - Week of January 30, 2013
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Product Detail
| Product Description | BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, labeled in part ***Becton, Dickinson and Company, Sparks MD 21152*** The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli. |
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| Recall Number | Z-0699-2013 |
| Classification | Class II |
| Code Info | Lot Number/ Exp Date 2086315 February 20, 2013 2101435 February 20, 2013 2104316 February 27, 2013 2129460 February 27, 2013 2129487 March 13, 2013 2163211 February 27, 2013 2163213 March 20, 2013 2163215 March 27, 2013 |
| Product Distributed Qty | 67,820 units |
| Reason For Recall | In-vitro diagnostic reagents for microbiological testing may be reversed in well positions in the test kit and when utilized may lead to bacteria misidentification. |
Event Detail
| Event Id | 63958 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Becton Dickinson & Co. |
| City | Sparks |
| State | MD | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-12-13 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution-USA including the states of MA, TN, KY, IN, GA, NC, TX, NY, FL, AZ, WA, NJ, MI, and CA, and the countries of Uruguay, Taiwan, Singapore, Australia, South Korea, Mexico, Hong Kong, Guatemala, Columbia, Chile, Canada, India, Japan, Brazil, China and Belgium. |
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