FDA Medical Device Recalls (openFDA)
DRG International, Inc.: DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
- Recall number
- Z-0921-2025
- Recalling firm
- DRG International, Inc.
- Product
- DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
- Status
- Open, Classified
- Initiated
- 2024-10-07
- Posted
- 2025-01-15
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- UDI: (01)04048474053616(17)20251130(10)429K084-1. Lot Number: 429K084-1
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CFP
- Firm FEI
- 2245285
- Firm city
- Springfield
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28