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U.S. Department of Health and Human Services

Class 2 Device Recall Randox Calcium (Ca) Colorimetric Method (reagent kit) for use on the RX Daytona Plus instrument

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  Class 2 Device Recall Randox Calcium (Ca) Colorimetric Method (reagent kit) for use on the RX Daytona Plus instrument see related information
Date Initiated by Firm December 04, 2018
Create Date February 15, 2019
Recall Status1 Terminated 3 on June 18, 2020
Recall Number Z-0839-2019
Recall Event ID 81746
510(K)Number K974607  
Product Classification Azo dye, calcium - Product Code CJY
Product Randox CALCIUM (Ca) Colorimetric Method RX Series
Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml
GTIN: 05055273200904
Code Information All lot codes
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.
FDA Determined
Cause 2		 Device Design
Action Randox the US distributor contacted customers by email on 12/4/18 to advise of problem and provided an update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments.The instrument testing order should be reviewed in line with the updated technical bulletin. A revised letter issued 12 Feb 2019 to advise "reagent would be observed as inconsistencies in Quality control recovery which may lead to a delay in running patient samples or erroneous elevated / depressed test results".
Quantity in Commerce 225 kits
Distribution WV, PR
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 = CJY and Original Applicant = RANDOX LABORATORIES, LTD.
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