Becton Dickinson Phoenix System Software, catalog # 448035/448046, component of BD automated microbiology system, and us
FDA device recall Z-1657-2012 · posted 2012-05-24 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- BD identified an increase in vancomycin-resistant strains that may exhibit erroneous results on all PMIC or PMIC/ID panels and could lead to ineffective treatment regimen in affected patients.
- Action taken
- Becton Dickinson (BD) sent an Urgent Field Correction Action letter dated April 2012 and an Update letter dated April 18, 2012 to all affected customers via e-mail and UPS overnight delivery. The letter identified the affected products, problem and actions to be taken. The letter provided specific workaround instructions for device users pending software upgrades. A BD Service Engineer will contact affected customers to arrange for the installation of the updated software when it becomes available. The letter included an Acknowledgement Form to be completed. For questions contact Technical Services at 800-638-8663.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LON
- Quantity affected
- 3,454,993 total products (U.S.)
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT ,DC ,FL , GA, IA, IL, IN, KY, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT,
- Date initiated
- 2012-04-10
- Date posted
- 2012-05-24
- Date terminated
- 2013-08-08
- Location
- Sparks, MD
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE (K030677) | Becton, Dickinson & CO | 2003-04-01 |