Recall Z-0975-2015 ยท JSG Culture Media, Non-Selective And Non-Differential
Becton Dickinson & Co.
CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an enriched, nonselective culture medium particularly useful or the isolation and cultivation of obligate anaerobes from clinical specimens. It supports the growth of a wide variety of obligately anaerobic, faculatively anaerobic, microaerophilic and aerobic bacteria.
| Date | Jan 14, 2015 (initiated Jun 6, 2014) |
| Status | Terminated |
| Reason | A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the packaging. The contamination is typically observed as 1-3 CFUs per plate when present. |
| Root cause | Material/Component Contamination |
| Action | BD Diagnostic Systems sent a Field Correction Notice dated August 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to continue to follow all surveillance requirements of their laboratory upon confirmation of Listeria monocytogenes. Laboratory staff should notify their respective state health department. Customers with questions should contact BD Technical Services at 800-638-8663. For questions regarding this recall call 410-316-4000. |
| Quantity | 1,530 cases (100 plates/case) |
| Distribution | Worldwide Distribution - US nationwide including Puerto Rico, Belgium, Canada, Philippines, Singapore, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K803025 | CDC ANAEROBE BLOOD AGAR Bd Becton Dickinson Vacutainer Systems Preanalytic, Dec 22, 1980 |