FDA Device recall Z-0413-2020
Randox Liquid Cardiac Controls Catalogue Number CQ5052
- FDA Device
- Class II
- terminated
- Published 2019-11-27
On 2019-11-27 the FDA classified a Class II recall of Randox Liquid Cardiac Controls Catalogue Number CQ5052 by Randox Laboratories, citing removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5052 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBN….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0413-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-04 |
| Published | 2019-11-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Randox Laboratories |
| Distribution | CA, CO, DE, GA, IN, MD, NJ, NY, PR, WV |
Product
Randox Liquid Cardiac Controls Catalogue Number CQ5052.
Reason
Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5052 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.
Identifiers
| code_info | Catalogue Number: CQ5052 GTIN: 05055273207453 Batch/lot: 4244CK (Exp. 28Nov2019), 4247CK (Exp. 28Nov2019), 4261CK (Ex…Catalogue Number: CQ5052 GTIN: 05055273207453 Batch/lot: 4244CK (Exp. 28Nov2019), 4247CK (Exp. 28Nov2019), 4261CK (Exp. 28Nov2019), 4312CK Exp. 28Jun2020) and 4315CK (Exp. 28Jun2020) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0413-2020%22
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