Recall Z-0381-2019 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Randox Laboratories Ltd.
Liquid Cardiac Control, CQ5052
| Date | Oct 2, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 1738 |
| Distribution | Distributed to IN, NY, PR, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110534 | RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3 Randox Laboratories Limited, Jan 23, 2012 |