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
Platelet assay, automated - Product Code JOZ
원인
The verifynow p2y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run.
조치
The 333 consignees were notified by regular mail or by E-mail on 9/5/2006 -- 9/13/2006. There were four versions of the notification letter tailored to (1) domestic customers; (2) domestic distributors; (3) international customers; and (4) international distributors. Each notification was accompanied by a 'fax back' form which customers were asked to sign and return to Accumetrics as an acknowledgement they received the notification letter.
The notification letter instructs consignees that test results with the VerifyNow P2Y12 Assay and all VerifyNow assays should be interpreted in conjunction with other clinical and laboratory data available to the clinician. Caution is advised when testing patients outside the ranges documented in the package insert.
Worldwide Distribution- USA, and countries of Australia, Canada, France, Germany, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Spain, Sweden, Switzerland, & United Kingdom
제품 설명
VerifyNow P2Y12 Assay Device Kit, Part Number 85054