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 analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml HbA1c R2: Agglutinator Reagent - 3 x 14 ml R3: Haemoglobin Denaturant Reagent - 3 x 50 ml Hb R1: Total Haemoglobin Reagent - 3 x 28 ml For Professional Use in the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood.
Enforcement
- Recall Number
- Z-0285-2018
- Event ID
- 77611
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Randox Laboratories Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- January 3, 2018
- Initiation Date
- June 7, 2017
- Classification Date
- December 22, 2017
- Termination Date
- July 2, 2018
- Address
- 55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland
Description
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 analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml HbA1c R2: Agglutinator Reagent - 3 x 14 ml R3: Haemoglobin Denaturant Reagent - 3 x 50 ml Hb R1: Total Haemoglobin Reagent - 3 x 28 ml For Professional Use in the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood.
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 the product.
Lot/Batch 414553, expiry 28th Jan 2019
Puerto Rico; International: Portugal, Italy, Turkey, Slovakia, Russia, Thailand and Vietnam
90 kits