Date Initiated by Firm |
December 04, 2018 |
Create Date |
February 15, 2019 |
Recall Status1 |
Terminated 3 on June 18, 2020 |
Recall Number |
Z-0840-2019 |
Recall Event ID |
81746 |
510(K)Number |
K182042
|
Product Classification |
Azo dye, calcium - Product Code CJY
|
Product |
Randox 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 |
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 |
1 kit |
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.
|