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
Anti-sm antibody, antigen and control - Product Code LKP
원인
All equivocal and positive results (greater or equal 7 elia u/ml) on elia smdp well lot 0018 may be incorrect and must be considered invalid. patient samples in complaint investigations caused unspecific signals up to 22 u/ml on elia smdp well lot 0018. the nonspecific signals are not caused by anti-sm antibodies, nor by streptavidin antibodies.
조치
On 12/28/2015, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions call 1-800-3464364, option #2.
US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR.
제품 설명
EliA SmDP Well, Article Number 14-5624-01 || Product Usage: || EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.