Becton Dickinson & Co.: Medical Device Recall in 2014 - (Recall #: Z-0869-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 9, 2013

Date Posted: February 5, 2014

Recall Number: Z-0869-2014

Event ID: 67245

Reason for Recall:

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

Status: Terminated

Product Quantity: 198 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated