Recall Z-1008-2010 ยท MDB System, Blood Culturing
Becton Dickinson & Co.
BD BACTEC(TM) Plus + Aerobic/F Medium, catalog 442192, packed in tubes, 50 tubes/case and labeled in part ***Becton Dickinson and Company, Sparks, MD 21152*** BD BACTEC Media are used in a qualitative procedure for the culture and recovery of microorganisms from blood.
| Date | Mar 8, 2010 (initiated Nov 11, 2009) |
| Status | Terminated |
| Reason | The draw volume on test tubes of blood culture medium is marked with graduations that may be confusing for healthcare practitioners using the tubes for appropriate collection of patient samples for microbiological laboratory testing. |
| Root cause | Component change control |
| Action | An "URGENT CUSTOMER NOTIFICATION" was sent via UPS to customers. The notification letter described the product, problem and action to be taken. The letter alerted customers that the firm had recently manufactured identified lots of BACTEC(tm) Blood Culture Media with a new label containing a red line which should not be used as an accurate indication for blood draw volume. The firm also advised that the manufacturer is working to build stock with a revised label, but all of the identified lots distributed had passed testing and release criteria and will continue to perform as expected when use |
| Quantity | 2,940,473 bottles |
| Distribution | Worldwide Distribution: USA and Canada, Japan, Australia, Singapore, Korea, Brazil, Taiwan, China, Mexico, Germany, New Zealand, Hong Kong, Uruguay |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K921133 | BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA Bd Becton Dickinson Vacutainer Systems Preanalytic, Apr 22, 1992 |