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PremierPro
PRESTIGE AMERITECH, LTD. · Model 6915 · UDI-DI 00818566016409
10
510(k) clearances
79
Adverse events
19
Recalls
64
Facilities
Description
Seracult Fecal Occult Blood Test, Triple Slide
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. |
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Get your free API keyRead the docsData 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.