DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Reported: January 22, 2025 Initiated: October 7, 2024 #Z-0921-2025
Product Description
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
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.
Details
- Recalling Firm
- DRG International, Inc.
- Units Affected
- 10 units
- Distribution
- Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.
- Location
- Springfield, NJ
Frequently Asked Questions
What product was recalled? ▼
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361. Recalled by DRG International, Inc.. Units affected: 10 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2025. Severity: Moderate. Recall number: Z-0921-2025.
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