Home › Device types › KHE
Reagent, Occult Blood
FDA product code KHE · Class 2 · Hematology
352
Registered devices
79
Adverse events
19
Recalls
97
510(k) clearances
Devices with this code
InSure® ONE™ — ENTERIX INC.Seracult Plus Fecal Occult Blood Test Developer — PROPPER MANUFACTURING COMPANY, INC.Gastrocult — Beckman Coulter, Inc.McKesson — MCKESSON MEDICAL-SURGICAL INC.InSure® ONE™ — ENTERIX INC.Rapid Response — BTNX Inchema-screen — Immunostics Company, IncOC-Light S — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCSURE-VUE FOBT TRIPLES 80/PK — FISHER SCIENTIFIC COMPANY L.L.C.McKesson — MCKESSON MEDICAL-SURGICAL INC.Fisher Labcorp ES Lab Pack 100 Count — FISHER SCIENTIFIC COMPANY L.L.C.McKesson — MCKESSON MEDICAL-SURGICAL INC.hema-screen ER — Immunostics Company, IncOC-Light S — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLChema-screen STAT — Immunostics Company, IncHemoccult — Beckman Coulter, Inc.HEMOSURE® — HEMOSURE INC.Hemoccult — Beckman Coulter, Inc.OC-Light S — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOC-Light S — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCPremierPro — PRESTIGE AMERITECH, LTD.HEMOSURE® — HEMOSURE INC.PremierPro — PRESTIGE AMERITECH, LTD.OC-Light S — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-09-17 | Enterix, Inc. | InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results. |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2020-10-08 | Enterix, Inc. | Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing un |
| 2019-02-27 | Cypress Medical Products LLC | Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to the packaging being too similar to domestically source |
| 2018-09-24 | Roche Diagnostics Corporation | Limits of Detection (LoD) for protein, nitrite, leukocytes, and erythrocytes on the Urisys 1100 urine analyzer with Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD |
| 2018-08-08 | Helena Laboratories, Corp. | The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly. |
| 2018-08-08 | Helena Laboratories, Corp. | The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly. |
| 2013-07-17 | Beckman Coulter Inc. | 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 inv |
| 2013-07-16 | Assuramed | The products may have been stored at temperatures outside their required storage conditions. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.