Drug recall
RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
FDA recall event 84007 · Class III · Randox Laboratories, Limited
Key facts
| Event ID | 84007 |
|---|---|
| Recall numbers | Z-0367-2020 |
| Recalling firm | Randox Laboratories, Limited |
| Product type | Devices |
| Products | RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing. |
| Initiation date | Sep 23, 2019 |
| Report date | Nov 20, 2019 |
| Termination date | May 7, 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: