Recall Z-0921-2025 ยท CFP Radioimmunoassay, Immunoreactive Insulin
DRG International, Inc.
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
| Date | Jan 15, 2025 (initiated Oct 7, 2024) |
| Status | Open, Classified |
| Reason | The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High) which causes a delay in results. |
| Root cause | Nonconforming Material/Component |
| Action | DRG International began notifying consignees on 10/07/2024 via letter. Consignees were instructed to check inventory for affected units, cease use of them, and quarantine all product. Arrange return of those units. Consignees were also instructed to notify customers if units were further distributed. |
| Quantity | 10 units |
| Distribution | Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.