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 Randox Blood Gas Control Level 2

  • 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 Randox Blood Gas Control Level 2 see related information
Date Initiated by Firm February 13, 2019
Create Date March 26, 2019
Recall Status1 Terminated 3 on April 14, 2020
Recall Number Z-1057-2019
Recall Event ID 82195
510(K)Number K093384  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product Randox Blood Gas Control Level 2 -Model BG5002.
In-vitro Diagnostic Quality control of Blood Gas analysis

This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.
Code Information Lot Code: 184BG GTIN: 05055273227116
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 An error in the assignment of the control range pH in Blood Gas Control
FDA Determined
Cause 2		 Process control
Action The firm, Randox Laboratories Ltd, sent an "Urgent Medical Device Correction " letter dated 2/13/2019 to its customer on 2/13/2019 via email. The letter describes the product, problem and actions to be taken. The customer was instructed todo the following: " Please replace the amended value sheet within the kit of any remaining stock. " Discuss the contents of this notice with your Medical Director. " Randox Laboratories Ltd is not recommending a review of previous results as any issue would be observed at the time of use. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. If you have any questions or concerns, please contact Randox Technical Services by email at technical.services@randox.com, or telephone +44 (0)28 9442 2413 or Email: vigilance@randox.com.
Quantity in Commerce 1 kit
Distribution US Distribution to state of: WV
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = JJY and Original Applicant = DIAMOND DIAGNOSTICS, INC.
-
-