The Recall Desk
HighFDA (Devices)·Z-0028-2014·Announced 2013-10-30

Becton Dickinson Recalls BBL MGIT Mycobacteria Tubes Due to Barcode Error

Becton Dickinson is recalling 187,000 BBL MGIT Mycobacteria Growth Indicator Tubes because incorrect barcodes may cause false negative test results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where a false negative result could lead to a missed diagnosis, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Becton Dickinson & Co. is recalling 187,000 units of the BBL MGIT Mycobacteria Growth Indicator Tube, part # 245122. The product is packaged in 100-count cartons and is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems.

The recall was initiated because the in-vitro diagnostic reagent may be labeled with an incorrect barcode. When these tubes are scanned on the associated diagnostic instrument, the error may cause a false negative result. The affected lots have expiration dates ranging from August 16, 2014, to September 12, 2014.

The product was distributed nationwide in the United States, specifically 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, and WI. Users should stop using the affected product and contact Becton Dickinson for further instructions.

The recalled product

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
Affected units
187,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically: