Reported Aug 28, 2013 · Terminated
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
- Lot codes and dates
- Part Number 395067. All In-date lots (42 lots total)
- Lot NumberManuf
- DateExp
- Date&
M20714327Jul201201/31/2014M20845421Sep201202/28/2014M21007919Oct201203/31/2014M21110030Nov201205/31/2014M21212220Dec201206/30/2014M21220317Jan201306/30/2014M30141822Feb2013
107 of 107 codes
28Feb201307/31/2014M20208624Feb201207/31/2013M20308116Mar201207/31/2013M203081A23Mar201207/31/2013M20326206Apr201208/31/2013M20309813Apr201208/31/2013M203098A20Apr201208/31/2013M203098B25Apr201208/31/2013M20308027Apr201210/31/2013M203080A04May201210/31/2013M203080B11May201210/31/2013M20427618May201209/30/2013M20519912May201209/30/2013M20528822May201211/30/2013M20602106June201211/30/2013M20616618June201212/31/2013M20707205July201212/31/2013M20714327July201201/31/2014M20625926June201212/31/2013M20733230July201201/31/2014M208345
- Amount recalled
- 68,116 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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