Recall Z-0523-2013— Becton Dickinson & Co.
Class II · Terminated
Class II FDA medical device recall by Becton Dickinson & Co., initiated 2012-10-22, terminated 2013-01-24. FDA's recall record names no specific 510(k) clearance for this event. 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***. 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..
- Recalling firm
- Becton Dickinson & Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-22
- Terminated
- 2013-01-24
- Firm location
- Sparks, MD, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.