FDA Device recall Z-0285-2018
Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD
- FDA Device
- Class II
- terminated
- Published 2018-01-03
On 2018-01-03 the FDA classified a Class II recall of Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD by Randox Laboratories, citing randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent may not continue to meet its specific performance characteristics througho….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0285-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-07 |
| Published | 2018-01-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Randox Laboratories |
| Distribution | PR |
Product
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
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.
Identifiers
| code_info | Lot/Batch 414553, expiry 28th Jan 2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0285-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.