Device 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.
Z-0870-2014
Product summary
- Event
- Event 67245
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-0870-2014
Official wording
Reason: Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.
Code information: Catalog number 442296
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to IN, AU, CN, AR, BE, PE, KR, BR, CO, SG, TH, BN, HK, JP, and CA.
Derived failure modes
-
Unknown
Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.