Recall Z-0366-2011 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Becton Dickinson & Co.
BD Phoenix" ID/AST Panels, Item # PMIC/ID-107, Catalog number 448607, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663***
| Date | Nov 15, 2010 (initiated May 14, 2010) |
| Status | Terminated |
| Reason | The diagnostic reagent packaging may not be completely sealed, which may cause substrate degradation, and produce incorrect test results, including false positive and false negative results. |
| Root cause | Packaging process control |
| Action | BD Diagnostic Systems issued an "Urgent Product Recall" letter dated May 2010 to direct accounts, identifying the affected product, potential impact, and actions to be taken by the customer. Accounts were requested to respond by returning the enclosed reply form indicating the number of replacements needed for the affected product to be discarded. For assistance iwth replacements, contact BD Customer Service at 800 675-0908. For other inquiries, contact BD Technical Services at 1 800-638-8663. |
| Quantity | 1675 units |
| Distribution | Nationwide Distribution: To direct accounts in CA, MD, NJ, PA. and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021954 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML Becton, Dickinson & CO, Aug 1, 2002 |