Z-0028-2014Class II

BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled...

Name: Z-0028-2014 BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled...
Creator: Becton Dickinson & Co.
Published: 2013-09-09
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2013-09-09 / Terminated / root cause: labeling and UDI

FDA source

Becton Dickinson & Co. began a recall of BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth... on 2013-09-09. FDA classified it as Class II and gives the reason as "An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative result". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0028-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-09
Posted: 2013-10-19
Terminated: 2013-10-29
Recalling firm: Becton Dickinson & Co
Product: BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).
Product code: MDB System, Blood Culturing
Reason for recall: An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated diagnostic instrument may cause a false negative result.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: BD sent an Urgent Product Recall letter dated September 2013 to customers identified as microbiology lab managers. The letter identified the affected product, problem and actions to be taken. The letter advised that referenced lot numbers may contain an overlabel barcode that may begin to lift, exposing the original incorrect barcode pictured in the notification. Customers were instructed to complete the attached form and fax to Regulatory Compliance 410-316-4258. For further assistance regarding replacements contact BD Customer Service Department at 1-800-675-0908 and all other inquiries contact BD Technical Services Department at 1-800-638-8663.
Quantity in commerce: 187,000 tubes
Distribution: USA Nationwide Disatribution in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, IL, KY, MA, ME, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TX, UT, VA, WA, WI
Product codes and lots: Lot Number/ Exp. Date 3070436 September 12, 2014 3042466 August 16, 2014 3053239 August 30, 2014 3053240 August 30, 2014 3061013 September 6, 2014 3061014 September 6, 2014 3070433 September 12, 2014 3070437 September 12 , 2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0028-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0028-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-19

Product code MDB

K974883Class IBactec Mgit 960 SystemBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1998-05-01

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)