FDA Device recall Z-0381-2019
Liquid Cardiac Control, CQ5052
- FDA Device
- Class II
- terminated
- Published 2018-11-14
On 2018-11-14 the FDA classified a Class II recall of Liquid Cardiac Control, CQ5052 by Randox Laboratories, citing 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, CQ5….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0381-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-02 |
| Published | 2018-11-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Randox Laboratories |
| Distribution | IN, NY, PR, WV |
Product
Liquid Cardiac Control, CQ5052
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.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0381-2019%22
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