FDA Medical devices recall ·
DRG:HYBRiD-XL Insulin recall
- Recall number
- Z-0921-2025
- Date
- (initiated October 7, 2024)
- Company / brand
- DRG International, Inc.
841 Mountain Ave, Springfield, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 10 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: (01)04048474053616(17)20251130(10)429K084-1. Lot Number: 429K084-1
Distribution
Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.
States: New Jersey
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0921-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.