Recall Z-0200-2015 ยท JSK Supplement, Culture Media
Remel Inc
Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella.
| Date | Nov 10, 2014 (initiated Oct 17, 2014) |
| Status | Terminated |
| Reason | Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila. |
| Root cause | Under Investigation by firm |
| Action | Thermo Fisher sent an Urgent Medical Device Recall letter dated October 17, 2014, to all affected customers. |
| Quantity | 16/10/100 ml, vial, pkgs |
| Distribution | Distributed in the states of ND, VT and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K831469 | LEGIONELLA CYE AGAR BASE & BCYE SUPPL Oxoid U.S.A., Inc., Jun 8, 1983 |