Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
데이터 추가 비고
원인
Siemens' complaint investigation has confirmed that the 'low calibrator deviation' calibration parameter may fall below the acceptable range causing an invalid calibration status which prevents customers from generating results for the bnp assay. when valid calibration and quality control (qc) are obtained patient results are valid and acceptable for reporting. when valid calibration is not achieved qc and patient testing cannot be performed.
Model Catalog: 02816634 (Lot serial: Ending in 191); Model Catalog: 02816138 (Lot serial: Ending in 191); Model Catalog: 02816634 (Lot serial: Ending in 189); Model Catalog: 02816138 (Lot serial: Ending in 189); Model Catalog: 02816634 (Lot serial: Ending in 188); Model Catalog: 02816634 (Lot serial: Ending in 186); Model Catalog: (Lot serial: Ending in 191); Model Catalog: (Lot serial: Ending in 189); Model Catalog: (Lot serial: Ending in 188); Model Catalog: (Lot serial: Ending in 186); Model Catalog: 02816138 (Lot serial: Ending in 186); Model Catalog: 02816138 (Lot serial: Ending in 188)
제품 설명
B-type Natriuretic Peptide (BNP) 100 test kit;B-type Natriuretic Peptide (BNP) 500 test kit