Recall Z-0870-2014 ยท MDB System, Blood Culturing
Becton Dickinson & Co.
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.
| Date | Jan 30, 2014 (initiated Dec 9, 2013) |
| Status | Terminated |
| Reason | Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens. |
| Root cause | Nonconforming Material/Component |
| Action | 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 affe |
| Quantity | 2 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to IN, AU, CN, AR, BE, PE, KR, BR, CO, SG, TH, BN, HK, JP, and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915796 | BACTEC 9240 SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic, Apr 22, 1992 |