Enforcement Report - Week of December 19, 2012
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Product Detail
| Product Description | BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds*** |
|---|---|
| Recall Number | Z-0523-2013 |
| Classification | Class II |
| Code Info | Lot number 2089253 |
| Product Distributed Qty | 650 vials |
| Reason For Recall | In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or misidentification of Hemophilus species present in patient specimens. |
Event Detail
| Event Id | 63723 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Becton Dickinson & Co. |
| City | Sparks |
| State | MD | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-10-22 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA (nationwide) to international customers in Belgium, India, Japan, South Korea, Thailand and Mexico |
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