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U.S. Department of Health and Human Services

Class 2 Device Recall ProTime Microcoagulation System

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  Class 2 Device Recall ProTime Microcoagulation System see related information
Date Initiated by Firm July 16, 2013
Date Posted September 13, 2013
Recall Status1 Terminated 3 on December 27, 2017
Recall Number Z-2198-2013
Recall Event ID 65980
510(K)Number K010599  
Product Classification Test, time, prothrombin - Product Code GJS
Product ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store the foil-pouched cuvettes refrigerated 2-8C (36 - 36F); MATERIALS PROVIDED; ProTime cuvettes with Tenderlett Plus; or; Protime3 cuvettes with Tenderlett Plus LV; Product Instructions; Antiseptic, gauze (with self-test package only); International Technidyne Corporation; 8 Olsen Avenue; Edison, NJ 08820 USA; a subsidiary of Thoratec Corporation

The ProTime Microcoagulation System consists of a portable, battery operated instrument and disposable cuvette for quantitative determination of prothrombin time (PT) from fingerstick whole blood or anticoagulant-free venous whole blood. There are two different types of cuvettes available for use with the ProTime Microcoagulation System: a ProTime cuvette and a ProTime3 cuvette. The ProTime cuvette is black color coded and utilizes three channels for the PT assays and two channels for integral controls. It requires approximately 65 ul of blood (approximately 3 drops). The ProTime3 cuvette is blue color coded and utilizes one channel for PT assay and two channels for integral controls. The ProTime3 cuvette requires approximately 27 ul of blood (approximately 1 large drop). The ProTime Microcoagulation System is intended for professional use in the management of patients treated with oral anticoagulants or for patient self-testing.
Code Information *** 1) Product Number: PRO3-25;  Lots: All Lots;  Independence Medical Catalog Number: 55L2101002;  *** 2) Product Number: PRO5-25;  Lots: All Lots;  Independence Medical Catalog Number: ICPRO525
Recalling Firm/
Manufacturer		 Assuramed
1810 Summit Commerce Par
K
Twinsburg OH 44087
Manufacturer Reason
for Recall		 The products may have been stored at temperatures outside their required storage conditions.
FDA Determined
Cause 2		 Storage
Action Independence Medical (im) sent an Urgent Product Recall letter dated July 16, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to identify and immediately cease the distribution of the recalled products, quarantine the recalled products, and contact the recalling firm at 800-860-8027 for instructions on how to return the recalled products. Consignees who further distributed the recalled products were requested to notify their customers of the recall. Consignees were also instructed to complete the Product Recall Acknowledgement Form and return the document by email to recall@indemed.com indicating receipt of the notification.Customers with questions were instructed to contact the product manufacturer for ProTime Disposable Cuvettes at 800-579-2255, DiaScreen Liquid Urine Controls at 800-818-8877, and Hemoccult II SENSA elite Dispensapak at 800-854-3633. For questions regarding this recall call 800-860-8027.
Quantity in Commerce 1) 72 units; 2) 56 units
Distribution Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GJS and Original Applicant = INTERNATIONAL TECHNIDYNE CORP.
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