The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2197-2013·Announced 2013-09-25

Assuramed Recalls Hemoccult II SENSA elite Fecal Occult Blood Test Kits

Assuramed is recalling Hemoccult II SENSA elite test kits because they may have been stored at temperatures outside required conditions.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential storage condition deviations without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Assuramed is recalling 13 units of Hemoccult II BRAND SENSA elite test kits. The recall involves Hemoccult II SENSA elite Slides, Developer solution, Applicator Sticks, and associated packaging materials. The products are identified by Product Number 9964130 and include all lots.

The recall was initiated because the products may have been stored at temperatures outside their required storage conditions. This deviation from storage requirements could potentially affect the integrity of the test materials.

The affected products were distributed nationwide, including in AR, AZ, CA, CO, FL, IL, KY, LA, MI, NJ, NY, OH, OK, OR, SC, TX, UT, and WA. Consumers and healthcare providers should stop using the recalled products and contact Assuramed for further instructions or a replacement.

The recalled product

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…
Manufacturer
Assuramed
Category
Medical Device — Diagnostic Test Kit
Hazard
Affected units
13

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Product Number: 9964130
  • Lots: All Lots
  • Independence Medical Catalog Number: 9964130

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Assuramed under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Assuramed

See all →

Same hazard · storage temperature

See all →

Similar recalls