Z-0285-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 3, 2018
- Initiation Date
- June 7, 2017
- Termination Date
- July 2, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90 kits
Product 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.
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 the product.
Distribution Pattern
Puerto Rico; International: Portugal, Italy, Turkey, Slovakia, Russia, Thailand and Vietnam
Code Information
Lot/Batch 414553, expiry 28th Jan 2019