Z-0869-2014Class II

BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386...

Name: Z-0869-2014 BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386...
Creator: Becton Dickinson & Co.
Published: 2013-12-09
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2013-12-09 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration... on 2013-12-09. FDA classified it as Class II and gives the reason as "Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0869-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-09
Posted: 2014-01-30
Terminated: 2014-08-20
Recalling firm: Becton Dickinson & Co
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.
Product code: MDB System, Blood Culturing
Reason for recall: Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 198 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.
Product codes and lots: Catalog number 441385 and 441386

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0869-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0869-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30
Z-0870-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30

Product code MDB

K915796Class IBactec 9240 SystemBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1992-04-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)