Devices

Device Recall HbA1c

Model / Serial
Lot/Batch 414553, expiry 28th Jan 2019
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Puerto Rico; International: Portugal, Italy, Turkey, Slovakia, Russia, Thailand and Vietnam
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.
Manufacturer
Randox Laboratories Ltd.
1 Event
- Recall of Device Recall HbA1c

Manufacturer

Randox Laboratories Ltd.

Manufacturer Address
Randox Laboratories Ltd., 55 Diamond Road, Crumlin (North) Ireland
Manufacturer Parent Company (2017)
Randox Holdings Limited
Source
USFDA

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