FDAFDA · Food and drugs·Recall number Z-0870-2014
BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.
Published February 5, 2014 · Recall initiated: December 9, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Becton Dickinson & Co.
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to IN, AU, CN, AR, BE, PE, KR, BR, CO, SG, TH, BN, HK, JP, and CA.
- Lot
- Catalog number 442296
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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