FDAFDA · Food and drugs·Recall number Z-0869-2014
BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The BD BACTEC FX 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 441385 and 441386
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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