FDA Enforcement
Class II
Terminated
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: Z-0523-2013
·
Reported December 19, 2012
Enforcement
- Recall Number
- Z-0523-2013
- Event ID
- 63723
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Becton Dickinson & Co.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 19, 2012
- Initiation Date
- October 22, 2012
- Classification Date
- December 13, 2012
- Termination Date
- January 24, 2013
- Address
- BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States
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***
Reason
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.
Code Info
Lot number 2089253
Distribution
Worldwide Distribution - USA (nationwide) to international customers in Belgium, India, Japan, South Korea, Thailand and Mexico
Quantity
650 vials