Z-2627-2011

BACTEC" FX Instrument-Top, catalog #441385. The BD BACTEC" FX instrument is designed for the rapid detection...

Name: Z-2627-2011 BACTEC" FX Instrument-Top, catalog #441385. The BD BACTEC" FX instrument is designed for the rapid detection...
Creator: Becton Dickinson & Co.
Published: 2010-08-10
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2010-08-10 / Terminated / root cause: software

FDA source

Becton Dickinson & Co. began a recall of BACTEC" FX Instrument-Top, catalog #441385. The BD BACTEC" FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens... on 2010-08-10. The reason FDA records is "In vitro diagnostic instrumentation may exhibit random operational errors that could delay effective patient treatment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2627-2011
Status: Terminated
Initiated: 2010-08-10
Posted: 2011-06-23
Terminated: 2011-07-05
Recalling firm: Becton Dickinson & Co
Product: BACTEC" FX Instrument-Top, catalog #441385. 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: In vitro diagnostic instrumentation may exhibit random operational errors that could delay effective patient treatment.
Root cause tag: software
FDA root cause: Software design
Action: BD Diagnostics Systems sent an "URGENT PRODUCT RECALL" letter dated August 2010 to all affected customers. The letter describes the product, problem and action to be taken. The letter described the type of error messages the customers may experience. All affected units will be scheduled for on site software update as well as a disk drive replacement. A BD field service engineer will contact the customers to schedule the on site visit. Customers experiencing issues prior to the scheduled visit or have questions should contact the BD Diagnostics Service Department at 800-638-8663.
Quantity in commerce: 907units
Distribution: Worldwide Distribution--USA (nationwide) including countries of Australia, Belgium, Canada, China, Colombia, New Zealand, Hong Kong, Japan, Korea, Philippines, Singapore, Taiwan, and Thailand.
Product codes and lots: Catalog # 441385-Serial numbers: FT-0001 to FT-0906 and FT-0922

Product code MDB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)