Recall Z-1997-2013 ยท KHE Reagent, Occult Blood
Beckman Coulter Inc.
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
| Date | Aug 22, 2013 (initiated Jul 17, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Beckman Coulter sent an Urgent Product Correction letter dated July 9, 2013, to all affected customers. The letter was accompanied with a cover letter and response form, dated July 9, 2013. Customers were informed of the product under recall with product description, actions to take, contact information, the issue, impact, and resolution. Beckman Coulter conducted a risk assessment for this issue. Per the risk documentation, there is only a remote probability that use of the product will cause any adverse health consequences,and the product is not likely to lead to serious adverse health |
| Quantity | 68,116 units |
| Distribution | Worldwide Distribution - USA and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080812 | HEMOCCULT ICT Beckman Coulter, Inc., Jun 25, 2008 |