Recall Z-1112-2014 ยท JSK Supplement, Culture Media
Remel Inc
Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental samples. When the product is added to CYE Agar base, it stabilizes pH and provides essential growth factors for the isolation
| Date | Feb 26, 2014 (initiated Jan 24, 2014) |
| Status | Terminated |
| Reason | The product may contain high levels of microbial contamination |
| Root cause | Unknown/Undetermined by firm |
| Action | Thermo Fisher sent an Urgent Medical Device Recall letter dated January 24, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Please notify any personnel who need to be aware of the potential for false presumptive Legionella spp. identification or masking of the recovery/isolation of Legionella spp. Review your inventory for the affected product and discard it. You should review results reported using these lots and consider retesting and/or seek appropriate expert advice. Return the attached Medical Device Rec |
| Quantity | 44/10/500-ml. vial boxes |
| Distribution | US Distribution including Puerto Rico and the states of FL, IL, MA, ME, MI, and PA. |
| 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 |