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U.S. Department of Health and Human Services

Class 2 Device Recall Randox Calcium (Ca) (for use on RX Daytona Plus instrument)

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 Class 2 Device Recall Randox Calcium (Ca) (for use on RX Daytona Plus instrument)see related information
Date Initiated by FirmDecember 04, 2018
Create DateFebruary 15, 2019
Recall Status1 Terminated 3 on June 18, 2020
Recall NumberZ-0840-2019
Recall Event ID 81746
510(K)NumberK182042 
Product Classification Azo dye, calcium - Product Code CJY
ProductRandox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368
Code Information All lot codes
FEI Number 1000361607
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
ActionRandox 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 Commerce1 kit
DistributionWV, PR
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.
510(K) Database510(K)s with Product Code = CJY
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