PlainRecalls
FDA Devices Moderate 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***

Reported: December 19, 2012 Initiated: October 22, 2012 #Z-0523-2013

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***

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.

Details

Recalling Firm
Becton Dickinson & Co.
Units Affected
650 vials
Distribution
Worldwide Distribution - USA (nationwide) to international customers in Belgium, India, Japan, South Korea, Thailand and Mexico
Location
Sparks, MD

Frequently Asked Questions

What product was recalled?
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***. Recalled by Becton Dickinson & Co.. Units affected: 650 vials.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 19, 2012. Severity: Moderate. Recall number: Z-0523-2013.