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 immunoassay

  • 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 immunoassaysee related information
Date Initiated by FirmDecember 21, 2021
Create DateApril 07, 2022
Recall Status1 Terminated 3 on February 12, 2024
Recall NumberZ-0896-2022
Recall Event ID 89680
Product Classification Radioimmunoassay, c-peptides of proinsulin - Product Code JKD
ProductC-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
Code Information Lot# / Expiration dates: 20K061 / 2022-06-30 20K071 / 2022-07-31 20K081 / 2022-08-31
Recalling Firm/
Manufacturer		 DRG International, Inc.
841 Mountain Ave
Springfield NJ 07081-3437
For Additional Information ContactSAME
973-564-7555
Manufacturer Reason
for Recall		ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
FDA Determined
Cause 2		Under Investigation by firm
ActionDRG issued letter via email on 12/28/21. Letter states reason for recall, health risk and Action to be taken by distributors and end-users: Please check your inventory for the respective lot, stop using these kits immediately and promptly quarantine these products. Only if you faced above mentioned issue of SO OD <1.2, please ask for replacement of the kits that were affected and provide your data. All unused kits of the affected lot will be replaced.Please reply immediately upon checking your stock/use to this notice to confirm. All replies should be received at once OR by January 7th, 2022. We sincerely apologize for the inconvenience this may have caused you and/or your Customer. Reply to email: qa@drg-international.com and copy drgsupport@drginternational.com.
Quantity in Commerce3 Kits
DistributionNY
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-