Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall DRG: HYBRiDXL Insulin

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall DRG: HYBRiDXL Insulinsee related information
Date Initiated by FirmOctober 07, 2024
Date PostedJanuary 15, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0921-2025
Recall Event ID 95785
Product Classification Radioimmunoassay, immunoreactive insulin - Product Code CFP
ProductDRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Code Information UDI: (01)04048474053616(17)20251130(10)429K084-1. Lot Number: 429K084-1
FEI Number 2245285
Recalling Firm/
Manufacturer		 DRG International, Inc.
841 Mountain Ave
Springfield NJ 07081-3437
For Additional Information ContactIna Hairston
973-564-7555
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionDRG International began notifying consignees on 10/07/2024 via letter. Consignees were instructed to check inventory for affected units, cease use of them, and quarantine all product. Arrange return of those units. Consignees were also instructed to notify customers if units were further distributed.
Quantity in Commerce10 units
DistributionWorldwide - US Nationwide distribution in the state of New Jersey and the countries of Czechia and Romania.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-