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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 Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and enhancer in an aqueous solution; Applicator Sticks; Patient Screening Kit Dispensing Envelopes with Patient Instructions; Flushable Collection Tissues; Mailing Pouches (for returning completed Test Cares); Hemoccult II SENSA elite Product Instructions; Beckman Coulter, Inc.; 250 S. Kraemer Blvd.; Brea, CA 92821 The Hemoccult II SENSA elite test is a rapid, convenient and qualitative method for detecting fecal occult blood which may be indicative of gastrointestinal disease. It is not a test for colorectal cancer or any other specific diseases. The Hemoccult II SENSA elite test is recommended for professional use as a diagnostic aid during routine physical examinations, for hospital patients to monitor for gastrointestinal bleeding in patients with iron deficiency anemia or recuperating from surgery, peptic ulcer, ulcerative colitis and other conditions, and in screening programs for colorectal cancer when the Patient Instructions are closely followed. Serial fecal specimen analysis is recommended when screening symptomatic patients. The Hemoccult II SENSA elite test and other unmodified guaiac tests are not recommended for use with gastric specimens.
Recall Number Z-2197-2013
Classification Class II
Code Info Product Number: 9964130; Lots: All Lots; Independence Medical Catalog Number: 9964130
Product Distributed Qty 13 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.