Recall Z-0921-2025— DRG International, Inc.
Class II · Ongoing
Class II FDA medical device recall by DRG International, Inc., initiated 2024-10-07. FDA's recall record names no specific 510(k) clearance for this event. Product: DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361. 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..
- Recalling firm
- DRG International, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-07
- Firm location
- Springfield, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.