Recall Z-0028-2014 ยท MDB System, Blood Culturing
Becton Dickinson & Co.
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
| Date | Oct 19, 2013 (initiated Sep 9, 2013) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974883 | BACTEC MGIT 960 SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic, May 1, 1998 |