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.
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