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Becton Dickinson & Co. recalls BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 2
Recalled February 5, 2014 · FDA recall Z-0870-2014 · Becton Dickinson &
Hazard
Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens. · FDA Class II
Units
2 units
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to IN, AU, CN, AR, BE, PE, KR, BR, CO, SG, TH, BN, HK, JP, and CA.
Description
Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.
Product
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.
Manufacturer(s)
Becton Dickinson & Co.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →