U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Supplement, culture media - Product Code JSK
원인
The product may contain high levels of microbial contamination.
조치
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 Recall Return Response acknowledging receipt of the notice and disposal of the affected product.
If you have further distributed these product lots, please contact those entities, advise them of the situation and provide them with a copy of this letter. You should insert your contact information, email, and fax numbers in the acknowledgement form and request that they return it to you.
If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
US Distribution including Puerto Rico and the states of FL, IL, MA, ME, MI, and PA.
제품 설명
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 of the Legionella spp.