DRG:HYBRiD-XL Insulin recall
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Why was DRG:HYBRiD-XL Insulin 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: (01)04048474053616(17)20251130(10)429K084-1. Lot Number: 429K084-1
- Product
- DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
- Recalling firm
- DRG International, Inc.
- Quantity
- 10 units
- Distribution
- Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.
- Recall date
- January 22, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)