Home › Device types › KHE
Reagent, Occult Blood
FDA product code KHE · Class 2 · Hematology
359
Registered devices
83
Adverse events
19
Recalls
97
510(k) clearances
Devices with this code
Henry Schein — HENRY SCHEIN, INC.ADS Medical — W.H.P.M. INC.QuickVue — QUIDEL CORPORATIONMcKesson — MCKESSON MEDICAL-SURGICAL INC.OC-Light S — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCMcKesson — MCKESSON MEDICAL-SURGICAL INC.MD DrugScreen — Medical Disposables CorpHEMOSURE® — HEMOSURE INC.Seracult Plus Single Slide Fecal Occult Blood Test — PROPPER MANUFACTURING COMPANY, INC.ColoScreen III Lab Pack — HELENA LABORATORIES CORPORATIONOC-Light S — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCOne Step — Zhejiang Orient Gene Biotech Co.,Ltd.OC-Light S — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCColoCARE Hospital Pack — HELENA LABORATORIES CORPORATIONEZ Detect Fecal Occult Blood Test — BIOMERICA, INC.Camco — CAMBRIDGE DIAGNOSTIC PRODUCTS INCSURE-VUE FOBT ES DEV15ML 20/PK — FISHER SCIENTIFIC COMPANY L.L.C.PremierPro — PRESTIGE AMERITECH, LTD.OC-Light S — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCADS Medical — W.H.P.M. INC.Seracult Plus Patient Kit Fecal Occult Blood Test — PROPPER MANUFACTURING COMPANY, INC.OC-Light S — POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLCMEDLINE — MEDLINE INDUSTRIES, INC.WELLlife™ — WONDFO USA CO., LTD.
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. |
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