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Open, Classified

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

FDA Recall Z-0921-2025 · Posted 2025-01-15

Recalling FirmDRG International, Inc.
Recall StatusOpen, Classified
Product CodeCFP
Date Initiated2024-10-07
Product Quantity10 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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