Hemoccult ICT — Class II medical device recall Z-1997-2013
Terminated recall by Beckman Coulter Inc., reported 2013-08-28. Beckman Coulter has received a customer complaint that suggests trending of positive results has increased fro
| Recall number | Z-1997-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2013-07-17 |
| Classified | 2013-08-22 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2014-10-24 |
| Countries outside the US | CA |
| Quantity | 68,116 units |
| Model numbers | 395067 |
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.
Reason for recall
Beckman Coulter has received a customer complaint that suggests trending of positive results has increased from approximately 4% to 1 0%. As a result of our investigation, Beckman Coulter has confirmed an increase in sensitivity at the borderline positive level. " This testing also demonstrated that the issue does not affect results reported as negative.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1997-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.