Device product
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***
Z-0523-2013
Product summary
- Event
- Event 63723
- Status
- Terminated
- Classification
- Class II
- Quantity
- 650 vials
- Official record key
device-enforcement:Z-0523-2013
Official wording
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 information: Lot number 2089253
Distribution pattern: Worldwide Distribution - USA (nationwide) to international customers in Belgium, India, Japan, South Korea, Thailand and Mexico
Derived failure modes
-
Unknown
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.