Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatogra

FDA device recall Z-1997-2013 · posted 2013-08-22 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

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.

Action taken

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 consequences. If you have any questions please call (714) 961-3777.

Root cause

Under Investigation by firm

Status

Terminated

Product code

KHE

Quantity affected

68,116 units

Distribution

Worldwide Distribution - USA and the country of Canada.

Date initiated

2013-07-17

Date posted

2013-08-22

Date terminated

2014-10-24

Location

Brea, CA

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