Reagent, Occult Blood

Fecal Occult Blood Test

Distribution without premarket approval/clearance.

InSure ONE Fecal Immunochemical Test. Labeled as follows:

InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.

a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult Blood Test (iFOB or FIT) Stool Sample 25 Tests, Model Number:

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a develo

The products may have been stored at temperatures outside their required storage conditions.

Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemog

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.

Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50.

The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative results when using the affected lots.

Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR.

The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative results when using the affected lots.

Clearview iFOB, Clearview iFOB Complete- Immunochemical Fecal Occult Blood Cassette Test

Potential for false negatives test results and negative/faint positive controls

Clearview iFOB, Clearview - Sample Kit (5 Test)Immunochemical Fecal Occult Blood Cassette Test

Potential for false negatives test results and negative/faint positive controls

Clearview iFOB, Clearview - Clearview iFOB Test Cassettes (25 Test)

Potential for false negatives test results and negative/faint positive controls