FDA Device recall Z-0921-2025
DRG:HYBRiD-XL Insulin
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of DRG:HYBRiD-XL Insulin by Drg International, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0921-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-07 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Drg International |
| Distribution | US |
Product
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
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.
Identifiers
| code_info | UDI: (01)04048474053616(17)20251130(10)429K084-1. Lot Number: 429K084-1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Drg International
- Sperm Ab ELISA
FDA Device · Class II · 2026-10-14 · Drg International - Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
FDA Device · Class III · 2025-08-13 · Drg International - 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-…
FDA Device · Class III · 2024-11-06 · Drg International - Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in…
FDA Device · Class III · 2024-08-21 · Drg International - C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine
FDA Device · Class II · 2022-04-13 · Drg International
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0921-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.