CLASS II Device recall · Reported 25 Sep 2013 · FDA Enforcement Report
Hemoccult II Sensa elite recalled by Assuramed
Assuramed is recalling Hemoccult II Sensa elite, distributed nationwide in the US. The recall was initiated on 16 Jul 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2197-2013
- FDA event ID
- 65980
- Recalling firm
- Assuramed, Twinsburg, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jul 2013
- FDA classified
- 13 Sep 2013
- Reported
- 25 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- E. coli
- Device type
- Patient Monitors
Timeline
| 16 Jul 2013 | Recall initiated by company | |
| 13 Sep 2013 | Classified by FDA | +59 days |
| 25 Sep 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The products may have been stored at temperatures outside their required storage conditions.
Some strains of E. coli, such as O157:H7, produce a toxin that can cause severe stomach cramps, bloody diarrhea and, in a small number of cases, kidney failure.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.
Nationwide ArkansasArizonaCaliforniaColoradoFloridaIllinoisKentuckyLouisianaMichiganNew JerseyNew YorkOhioOklahomaOregonSouth CarolinaTexasUtahWashington
Questions about this recall
Is Hemoccult II Sensa elite recalled?
Yes. Assuramed recalled Hemoccult II Sensa elite on 16 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-2197-2013.
Why was it recalled?
The products may have been stored at temperatures outside their required storage conditions.
Which lots are affected?
Product Number: 9964130; Lots: All Lots; Independence Medical Catalog Number: 9964130
Where was it sold?
Nationwide Distribution including AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH,OK, OR, SC, TX, UT, and WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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