Z-0921-2025Class II

DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

Name: Z-0921-2025 DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Creator: DRG International, Inc.
Published: 2024-10-07
License: https://open.fda.gov/license/

DRG International, Inc. / initiated 2024-10-07 / Open, Classified / root cause: manufacturing process

FDA source

DRG International, Inc. began a recall of DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361 on 2024-10-07. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0921-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-07
Posted: 2025-01-15
Recalling firm: DRG International, Inc.
Product: DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Product code: CFP Radioimmunoassay, Immunoreactive Insulin
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 10 units
Distribution: Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.
Product codes and lots: UDI: (01)04048474053616(17)20251130(10)429K084-1. Lot Number: 429K084-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0921-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0921-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-15

Product code CFP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)