CLASS II Device recall · Reported 30 Oct 2013 · FDA Enforcement Report

BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # recalled

Becton Dickinson & is recalling BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, distributed nationwide in the US. The recall was initiated on 9 Sep 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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

Quantity recalled187,000 tubes

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0028-2014
FDA event ID: 66325
Recalling firm: Becton Dickinson &, Sparks, MD
Classification: Class II
Status: Terminated
Recall initiated: 9 Sep 2013
FDA classified: 19 Oct 2013
Reported: 30 Oct 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

9 Sep 2013	Recall initiated by company
19 Oct 2013	Classified by FDA	+40 days
30 Oct 2013	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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).

Where it was distributed

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

Nationwide Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Illinois Kentucky Massachusetts Maine Minnesota Missouri North Carolina North Dakota New Jersey Nevada New York Ohio

Questions about this recall

Is BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122 recalled?

Yes. Becton Dickinson & recalled BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122 on 9 Sep 2013. The recall is Class II and its status is Terminated. Recall number Z-0028-2014.

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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