Liquid Cardiac Control, CQ5053
Recall
- Recall Number
- Z-0382-2019
- Event Number
- 81159
- Firm
- Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
- FEI Number
- 1000361607
- Product Code
- JJY
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- October 2, 2018
- Terminated
- May 30, 2019
Description
Liquid Cardiac Control, CQ5053
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.
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 [email protected] within five working days. - Contact your local Randox sales representative for alternative product details. You may contact the firm at [email protected].
Distributed to IN, NY, PR, and WV.
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