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.

Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.

BD Diagnostics initiated a field correction by phone on December 9, 2013, to affected customers and followed the calls with letters, e-mails, or fax. BD Diagnostics sent a secondary Urgent Field Corrective Action letter dated November 2013 to all affected customers. The recalling firm Secondary notifications were serial number specific and explained that some BD BACTEC FX instruments contain racks that may demonstrate variable indicator light intensities. Specifically, the Anonymous vial indicator lights which should appear yellow may instead appear more green in color. BD noted that affected instruments continue to function properly and will not report an incorrect result. The issue is limited to the yellow indicator lights only. Red and green indicator lights appear as intended. BD is developing software to correct this issue and anticipates that the new software will be available to begin instrument updates by February, 2014. The new software will not affect instrument if the indicator lights are functioning as intended. Until the software can be updated on your instrument, BD provided workflow instructions to ensure that the indicator light issue does not occur. For questions regarding this recall call 410-316-4054.