Drug recall
Randox Liquid Cardiac Controls Catalogue Number CQ5051
FDA recall event 84044 · Class II · Randox Laboratories, Limited
Key facts
| Event ID | 84044 |
|---|---|
| Recall numbers | Z-0412-2020, Z-0413-2020, Z-0414-2020 |
| Recalling firm | Randox Laboratories, Limited |
| Product type | Devices |
| Products | Randox Liquid Cardiac Controls Catalogue Number CQ5051, Randox Liquid Cardiac Controls Catalogue Number CQ5052., Randox Liquid Cardiac Controls Catalogue Numbers CQ5053. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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., Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots… |
| Initiation date | Oct 4, 2019 |
| Report date | Nov 27, 2019 |
| Termination date | Jul 6, 2020 |
| City | Crumlin |
| Country | United Kingdom |
| FEI number | 1000361607 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: