Device product
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.
Z-0869-2014
Product summary
- Event
- Event 67245
- Status
- Terminated
- Classification
- Class II
- Quantity
- 198 units
- Official record key
device-enforcement:Z-0869-2014
Official wording
Reason: Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.
Code information: Catalog number 441385 and 441386
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.