Summary
The FDA issued a Class II for DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361 by DRG International, Inc.. 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 de.
Details
Source
Device Recall
External ID
Z-0921-2025
Action Date
2025-01-22
Status
Ongoing
Category
device
Product Description
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Lot/Code Info: UDI: (01)04048474053616(17)20251130(10)429K084-1. Lot Number: 429K084-1
Quantity Affected: 10 units
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.
Distribution
Worldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-07
Company
Springfield, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DRG International, Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DRG International, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DRG International, Inc. have FDA actions?
DRG International, Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0921-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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