Beckman Coulter Recalls Hemoccult ICT Fecal Occult Blood Test Kits
Beckman Coulter is recalling 68,116 Hemoccult ICT units due to increased sensitivity at borderline positive levels, which may cause false positives.
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, but the hazard is a diagnostic accuracy issue (increased sensitivity/false positives) rather than a direct physical injury or high-risk pathogen, fitting the Moderate category for low-risk contamination or labeling/accuracy errors.
Plain-English summary
Beckman Coulter Inc. is recalling 68,116 units of the Hemoccult ICT (Immunochemical Fecal Occult Blood Test). This product is a rapid, visually read, qualitative immunochemical chromatographic method used to detect human hemoglobin in fecal samples. The affected units were distributed in the United States and Canada.
The recall was initiated after a customer complaint indicated that the rate of positive results had increased from approximately 4% to 10%. An investigation by Beckman Coulter confirmed an increase in sensitivity at the borderline positive level. The company noted that this issue does not affect results reported as negative.
The recall includes all in-date lots (42 lots total) for Part Number 395067. Consumers and healthcare providers should stop using the affected test kits and contact Beckman Coulter for instructions on returning the product.
The recalled product
- Product
- Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
- Manufacturer
- Beckman Coulter Inc.
- Category
- Medical Device — Diagnostic Test
- Affected units
- 68,116
Distribution
Distribution scope not specified by the agency.
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