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
Prostate-specific antigen (psa) for management of prostate cancers - Product Code LTJ
원인
Qualigen initiated this recall because the fastpack kit may cause lower than expected results due to a manufacturing defect.
조치
Qualigen, Inc., notified customers of the recall by calling customers via telephone (with a telephone script) on 11/08/2013. The telephone (script) included the reason for recall, product description with codes, instructions and contact information. The customers were instructed to examine your inventory and discontinue use of the kits immediately. Qualigen will send you
replacement kits and provide you with a shipping label to return all of the defective kits including any that were partially used.
Feel free to contact System Support at 760.579.6900 if you have any
questions or require assistance with returning your kits.
US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
제품 설명
FastPack Total PSA Immunoassay || Chemilunescence assay for the determination of Total PSA. || FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack Total PSA Immunoassay is designed for use with the FastPack System.