Reported Jan 22, 2025 · Ongoing
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
DRG International, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DRG International, Inc. · 841 Mountain Ave · Springfield, NJ · 07081-3437
Is this the product you have?
- DRGHYBRiD-XL Insulin
- Model/Catalog NumberHYE-5361
- Lot codes and dates
- UDI(01)04048474053616(17)20251130(10)429K084-1
- Lot Number429K084-1
- Amount recalled
- 10 units
Where it was sold
- Nationwide
- NJ
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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