Z-2143-2011

BACTEC(tm) MGIT(tm) 5-Tube Spare AST Set Carrier, Bag of 3, Catalog 445943. ***Becton, Dickinson and Company...

Name: Z-2143-2011 BACTEC(tm) MGIT(tm) 5-Tube Spare AST Set Carrier, Bag of 3, Catalog 445943. ***Becton, Dickinson and Company...
Creator: Becton Dickinson & Co.
Published: 2010-08-31
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2010-08-31 / Terminated / root cause: labeling and UDI

FDA source

Becton Dickinson & Co. began a recall of BACTEC(tm) MGIT(tm) 5-Tube Spare AST Set Carrier, Bag of 3, Catalog 445943. ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152*** The... on 2010-08-31. The reason FDA records is "In vitro diagnostic device components are mislabeled". 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-2143-2011
Status: Terminated
Initiated: 2010-08-31
Posted: 2011-05-05
Terminated: 2011-07-08
Recalling firm: Becton Dickinson & Co
Product: BACTEC(tm) MGIT(tm) 5-Tube Spare AST Set Carrier, Bag of 3, Catalog 445943. ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152*** The BACTEC MGIT AST system is a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin, isoniazid, rifampin, ethambutol, and pyrazinamide. The routine AST set consists of a Growth Control tube and one tube for each drug, as well as a barcoded tube carrier that holds the set. The barcode provides set size and identification. A tube rack capable of holding up to 55 AST tubes in various set combinations is available for tube setup and transport. (Large or small AST carrier sets can be placed in the rack also.) The MGIT AST system is based on growth of the Mycobacterium tuberculosis strain under test as measured by the instrument. AST sets are entered into the BACTEC MGIT 960 instrument and are tested automatically. Analysis of fluorescence in a drug containing tube is compared to the fluorescence of the Growth Control tube to determine susceptibility results.
Product code: MJA Susceptibility Test Powders, Antimycobacterial
Reason for recall: In vitro diagnostic device components are mislabeled.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: BD Diagnostic Systems sent an Urgent Product Recall letter on August 31, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter advised customers to discard any carriers or labels that contain the incorrect barcode for replacement. Accounts were requested to complete an attached reply form to acknowledge their receipt of the notification and fax it to 410-316-4258. For questions regarding this recall call BD Customer Service at 1-800-675-0908.
Quantity in commerce: 4123 total labels
Distribution: Worldwide Distribution - USA including CA, MA, MD, VA and the countries of Argentina, Colombia, Belgium, China, India, Hong Kong, Peru, Singapore, Thailand, and Trinidad.
Product codes and lots: not coded

Product code MJA

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)