BD BACTEC(tm) MGI (tm) System Software, Catalog 445922, Lot V5.02A. Product Usage: The BACTEC(tm) MGIT (tm) System Softw
FDA device recall Z-2890-2011 · posted 2011-07-28 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- Software contained three additional set configurations which caused the system to reinitialized the AST set carrier defaults.
- Action taken
- 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 further assistance is needed regarding replacements and all other inquires, please contact BD Technical Services and Support at 1-800-638-8663.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- MDB
- Quantity affected
- 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, T
- Date initiated
- 2011-03-28
- Date posted
- 2011-07-28
- Date terminated
- 2011-07-29
- Location
- Sparks, MD
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BACTEC MGIT 960 SYSTEM (K974883) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-05-01 |