Date Initiated by Firm |
February 07, 2019 |
Create Date |
April 08, 2019 |
Recall Status1 |
Terminated 3 on June 08, 2020 |
Recall Number |
Z-1107-2019 |
Recall Event ID |
82184 |
510(K)Number |
K112337
|
Product Classification |
Multi-analyte controls, all kinds (assayed) - Product Code JJY
|
Product |
Liquid Immunoassay Premium Controls, Model Number LIA3105
Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
|
Code Information |
Lot codes: 1723EC |
Recalling Firm/ Manufacturer |
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
|
Manufacturer Reason for Recall |
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
|
FDA Determined Cause 2 |
Employee error |
Action |
Urgent Medical Device Correction letters dated 2/7/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions contact Randox Technical Services. |
Quantity in Commerce |
4 |
Distribution |
The products were distributed to the following US states: WV and Puerto Rico. |
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 = RANDOX LABORATORIES, LTD.
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