Recall Z-0974-2015 ยท JSI Culture Media, Selective And Differential
Becton Dickinson & Co.
TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.
| 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 | 7,617 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
This recall record lists no 510(k) number.