Recall Z-0870-2014— Becton Dickinson & Co.

Name: FDA recall Z-0870-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-09

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2013-12-09, terminated 2014-08-20. It names one FDA 510(k) clearance: K915796. 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.. Reason: Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens..

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Terminated
Initiated: 2013-12-09
Terminated: 2014-08-20
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K915796 — BACTEC 9240 SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic·cleared 1992-04-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.