Z-0523-2013 Class II Terminated
FDA device recall Z-0523-2013 was initiated by Becton Dickinson & Co. on Oct 22, 2012 and is designated Class II. 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. The recall status is terminated (terminated Jan 24, 2013). Affected quantity: 650 vials.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 19, 2012
- Initiation Date
- Oct 22, 2012
- Termination Date
- Jan 24, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 650 vials
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) to international customers in Belgium, India, Japan, South Korea, Thailand and Mexico
Code Information
Lot number 2089253
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0523-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026