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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description 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.
Recall Number Z-2198-2013
Classification Class II
Code Info *** 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
Product Distributed Qty 1) 72 units; 2) 56 units
Reason For Recall The products may have been stored at temperatures outside their required storage conditions.

Event Detail

Event Id 65980
Product Type Devices
Status Ongoing
Recalling Firm Assuramed
City Twinsburg
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.