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.
Itc has determined that some citrate aptt cuvettes may recover higher than expected results in normal individuals.
조치
The firm, ITC The Point of Care, sent an "URGENT MEDICAL DEVICE RECALL" letter dated December 19, 2013 a long with an attached Health Professional Account Tracking Form via UPS to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to forward this communication to all those within your organization who need to be aware of this matter including any facility that you forwarded any of the affected product to; check all inventory to determine if you have any of the affected lots listed; if you have any affected lots, stop using them, remove from inventory and return to ITC; complete the attached Health Professional Account Tracking Form and return it within 10 days via fax to: 866-429-3132, email: RA@itcmed.com or mail to: ITC Technical Support, 20 Corporate Place South - Piscataway, NJ 08854 . It is important that you complete the form whether or not you have remaining inventory of these lots. In addition, contact ITC Technical Support immediately if you become aware of an unreported adverse event related to the use of affected J103C cuvettes.
ITC will review your response form and will contact you to arrange for any
inventory to be returned to ITC and ITC will replace all unused, returned product.
If you have questions, please contact ITC Technical Support: Telephone 800-579-2255 or 732-548-5700, Extension 4011 or E-mail Techsupport@itcmed.com.
Worldwide Distribution: US (nationwide) and countries of: Austria, Belgium, Canada, Serbia, Germany, Estonia, Italy, Spain and Saudia Arabia.
제품 설명
Hemochron Jr. Citrate APTT Cuvette || 510(k) K014008 || A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.