DRG:HYBRiD-XL Insulin (DRG International) – Recalibration Failure (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Brand
DRG International, Inc.
Lot Codes / Batch Numbers
UDI: (01)04048474053616(17)20251130(10)429K084-1. Lot Number: 429K084-1
Products Sold
UDI: (01)04048474053616(17)20251130(10)429K084-1. Lot Number: 429K084-1
DRG International, Inc. is recalling DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361 due to 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 de. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026