Drug recall
K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R)…
FDA recall event 77916 · Class II · Kamiya Biomedical Company, LLC
Key facts
| Event ID | 77916 |
|---|---|
| Recall numbers | Z-3138-2017 |
| Recalling firm | Kamiya Biomedical Company, LLC |
| Product type | Devices |
| Products | K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R)… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct. |
| Initiation date | Jul 19, 2017 |
| Report date | Sep 27, 2017 |
| Termination date | Nov 20, 2018 |
| City | Tukwila |
| State | WA |
| Country | United States |
| FEI number | 2084025 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: