Recall Z-0570-2013 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Becton Dickinson & Co.
BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria.
| Date | Dec 19, 2012 (initiated Nov 6, 2012) |
| Status | Terminated |
| Reason | An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, BD, sent an "URGENT PRODUCT RECALL" letter dated November 2012 via the telephone and fax to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and discard any remaining packages for replacement and to complete and return the Acknowledgement Receipt Form, whether or not you have any inventory remaining, via fax to: BD Regulatory Compliance at 410-316-4258. BD will issue replacements for the discarded materials. If further assistance is needed regarding replacements please contact BD Customer S |
| Quantity | 12,250 tests |
| Distribution | Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070809 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML Becton, Dickinson & CO, Sep 24, 2007 |