Recall Z-2890-2011 ยท MDB System, Blood Culturing
Becton Dickinson & Co.
BD BACTEC(tm) MGI (tm) System Software, Catalog 445922, Lot V5.02A. Product Usage: The BACTEC(tm) MGIT (tm) System Software is used in the MGIT 960 and MGIT 320 instruments for the rapid detection of mycobacteria from clinical specimens. In addition, an Antimicrobial/Drug Susceptibility Testing (AST or DST) system is used as a rapid qualitative procedure for susceptibility testing of Mycobacter
| Date | Jul 28, 2011 (initiated Mar 28, 2011) |
| Status | Terminated |
| Reason | Software contained three additional set configurations which caused the system to reinitialized the AST set carrier defaults. |
| Root cause | Software design (manufacturing process) |
| Action | BD Diagnostic Systems verbally notified all affect customers via the telephone on March 28, 2011. The notification identified the product, the problem, and the action to be taken by the customer. An "URGENT PRODUCT RECALL" follow-up letter was mailed to all customers on April 8, 2011 via UPS. Customers were instructed to complete and fax the attached reply form to acknowledge their receipt of the notification to Regulatory Compliance, 410-316-4256. The letter instructs customers to refer to the modified release notes and IMPORTANT NOTICES outlined in the attached notification letter. If |
| Quantity | 421 disks |
| Distribution | Nationwide Distribution (USA) including states of: AK, AL, AR, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and 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 |