Home › IMMUNALYSIS CORP › Immunalysis
Immunalysis
IMMUNALYSIS CORP · Model 504-0025 · UDI-DI 00840937110355
1
510(k) clearances
9
Adverse events
6
Recalls
25
Facilities
Description
Ethyl Alcohol Enzyme Assay
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2020-02-14 | Siemens Healthcare Diagnostics, Inc. | The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval. |
| 2019-01-16 | Carolina Liquid Chemistries | Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality control specifications. The defective lots will not function toward the e |
| 2019-01-16 | Carolina Liquid Chemistries | |
| 2019-01-11 | Lin-Zhi International Inc | Shelf life of the product may be reduced due to degradation of the assay. |
| 2010-11-01 | Express Diagnostics Int'l., Inc. | Express Diagnostics Intl'l Inc is recalling DrugCheck devices because they were informed via letter from the alcohol test strip manufacturer on October 27, 2010 that the product |
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 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.