Home › GERMAINE LABORATORIES, INC › COMPLIANCE GOLD FECAL OCCULT BLOOD TEST – ER, 100 SINGLE SLIDES

COMPLIANCE GOLD FECAL OCCULT BLOOD TEST – ER, 100 SINGLE SLIDES

GERMAINE LABORATORIES, INC · Model 74200 · UDI-DI 00695684742003

KHE Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Fecal occult blood rapid assay for the qualitative detection of occult blood in human stool samples.

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 lots received between 0
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 unnecessary follow-up
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 sourced products under the
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, and Chemstrip 10 U
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 investigation, Beckman
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 key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.