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BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part… recallZ-0028-2014 · Becton Dickinson & Co. · initiated Sep 9, 2013

Class II Terminated All recalls posted in October 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Co. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Error in labeling

What the company is doing

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.

Recall details

Recall number
Z-0028-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 9, 2013
Posted by the FDA
Oct 19, 2013
Recalling firm
Becton Dickinson & Co.
Quantity
187,000 tubes
Product code
MDB
FDA submissions
K974883
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 description

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).

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

6 devices cleared under K974883 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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