Date Initiated by Firm |
April 05, 2024 |
Date Posted |
May 09, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1786-2024 |
Recall Event ID |
94371 |
510(K)Number |
K220451
|
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
Product |
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115 |
Code Information |
GTIN: 05055273214970
Serial Numbers:
052-23-0424
052-23-0425
052-23-0434
052-23-0437
052-23-0618
052-23-0611
052-23-0516
052-23-0522
052-23-0490
052-23-0491
052-23-0439
052-23-0440
052-23-0441
052-23-0445
052-23-0449
052-23-0450
052-23-0451
052-23-0452
052-23-0438
052-22-0276
052-22-0277
052-22-0279
052-23-0416
052-22-0283
052-22-0271
052-21-0260
052-21-0255
052-21-0249
052-23-0418
052-23-0419
052-23-0415
052-23-0417
052-22-0268
052-23-0420
052-22-0284
052-23-0448
052-23-0444
052-23-0443
052-23-0442
052-23-0609
|
Recalling Firm/ Manufacturer |
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
|
Manufacturer Reason for Recall |
Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay in reporting results.
|
FDA Determined Cause 2 |
Device Design |
Action |
Randox Laboratories Ltd UK notified the US Distributor Randox Laboratories via email on 4/05/ 24. End-Users notified by email on 4/9/24.
Letter (REC736) states reason for recall, health risk and action to take:
" Export support files for the last 10 samples run and share with Randox using the link
to be provided
" Discuss the contents of this notice with your Medical Director.
" Complete and return the response form 12187-QA to technical.services@randox.com
within five working days.
" Affected chip heater assembly replacement to be arranged by Randox Service
Engineer Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation |
Quantity in Commerce |
40 units |
Distribution |
US Nationwide distribution. |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = JJE and Original Applicant = Randox Laboratories Limited
|