Recall Z-0981-2019 ยท PIC Oral Electronic Vision Aid
Becton Dickinson & Co.
BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacterial Panel performed on the BD MAX System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens.
| Date | Jan 14, 2019 |
| Status | Terminated |
| Reason | False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides targets of the BD MAX Extended Enteric Bacterial Panel assay. |
| Root cause | Nonconforming Material/Component |
| Action | BD Diagnostic Systems issued "URGENT MEDICAL DEVICE PRODUCT ADVISORY" Customer letters via UPS on January 14, 2019. The letters described the product, problem, and actions to take. The customers were instructed to do the following: 1. Complete the attached Customer Response Form and return to BD Regulatory Compliance at Email: BDRC3@bd.com or Fax to: No.: 410-316-4258 whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. 2. Although prevalence rates are considered to be low, if no other cause of enteric infection is determined you m |
| Quantity | 1583 assay kits |
| Distribution | Worldwide Distribution: US (nationwide) to states of:CA, GA, HI, ID, MI, MN, MT, NJ, NM, OH, OR, PA, SC, TX, VA, VT, WA ; and to countries of: Australia, New Zealand, Canada, Europe, and Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140111 | BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT Becton, Dickinson and Company, May 6, 2014 |