Z-2197-2013Class II

Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares)...

Name: Z-2197-2013 Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares)...
Creator: Assuramed
Published: 2013-07-16
License: https://open.fda.gov/license/

Assuramed / initiated 2013-07-16 / Terminated

FDA source

Assuramed began a recall of Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a... on 2013-07-16. FDA classified it as Class II and gives the reason as "The products may have been stored at temperatures outside their required storage conditions". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2197-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-16
Posted: 2013-09-13
Terminated: 2017-12-27
Recalling firm: Assuramed
Product: 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.
Product code: KHE Reagent, Occult Blood
Reason for recall: The products may have been stored at temperatures outside their required storage conditions.
FDA root cause: 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 [email protected] 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: 13 units
Distribution: Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.
Product codes and lots: Product Number: 9964130; Lots: All Lots; Independence Medical Catalog Number: 9964130

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2197-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2196-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-13
Z-2197-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-13
Z-2198-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-13

Product code KHE

K080812Class IIHemoccult IctBeckman Coulter, Inc. / cleared 2008-06-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)