Date Initiated by Firm |
October 02, 2018 |
Create Date |
November 03, 2018 |
Recall Status1 |
Terminated 3 on May 30, 2019 |
Recall Number |
Z-0381-2019 |
Recall Event ID |
81159 |
510(K)Number |
K110534
|
Product Classification |
Multi-analyte controls, all kinds (assayed) - Product Code JJY
|
Product |
Liquid Cardiac Control, CQ5052 |
Code Information |
All lots |
Recalling Firm/ Manufacturer |
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
|
Manufacturer Reason for Recall |
Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
On October 2, 2018, the firm notified distributors of the recall via Expanded Urgent Medical Device Correction email. Customers were informed that the recall was related to previous recall REC334 on June 8, 2018. The firm has confirmed that Liquid Cardiac Controls CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.
Customers were advised to take the following actions:
- Discontinue use of these products for the Quality Control (QC) monitoring of Troponin T assays.
- Discuss the contents of this notice with your Medical Director.
- Update kits with revised IFUs excluding Troponin T values and the attached important notice to prevent further use of the device in the QC of Troponin T assays.
- Complete and return the vigilance response section of this form to technical.services@randox.com within five working days.
- Contact your local Randox sales representative for alternative product details.
You may contact the firm at technical.services@randox.com. |
Quantity in Commerce |
1738 |
Distribution |
Distributed to IN, NY, PR, and WV. |
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 LIMITED
|