Recall Z-0324-2013 ยท MDB System, Blood Culturing
Biomerieux Inc
bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 412002 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety
| Date | Nov 16, 2012 (initiated Oct 16, 2012) |
| Status | Terminated |
| Reason | The product may mislabel patient information on culture specimen bottles due to a software miscommunication. |
| Root cause | Software design |
| Action | BIOMERIEUX sent an Urgent Product Correction Notice to all affected customers starting on October 16, 2012, The letter identified the affected product, the problem, and the action to be taken by hte customer. The firm provided modified instructions for use to clarify how to properly load bottles and to provide appropriate cautions and warnings concerning bottle loading. Customers were instructed to ensure that the letter and guidance on how to properly scan and load bottles is distributed, and training is provided to all appropriate personnel within their organization. Check for lost bott |
| Quantity | 83 kits |
| Distribution | Worldwide Distribution - USA including AR, AZ, CA, FL, KS, LA, MD, MN, MT, NC, NV, NY, OR, PA, RI, SC, TX, VA and WA. Internationally to Argentina, Armenia, Austria, Bangladesh, Bosnia and Herzegowina, Brazil, Bulgaria, Burkina FASO, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, COTE DIVOIRE, CROATIA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.