Drug recall
Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD., This…
FDA recall event 77611 · Class II · Randox Laboratories Ltd.
Key facts
| Event ID | 77611 |
|---|---|
| Recall numbers | Z-0285-2018 |
| Recalling firm | Randox Laboratories Ltd. |
| Product type | Devices |
| Products | Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent may not continue to meet its specific performance characteristics throughout the shelf life of… |
| Initiation date | Jun 7, 2017 |
| Report date | Jan 3, 2018 |
| Termination date | Jul 2, 2018 |
| City | Crumlin (North) |
| Country | Ireland |
| FEI number | 2965 |
At a glance
- 1–9 Products in this recall
- None 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: