# FDA recall Z-0285-2018

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2017-06-07.

## 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 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

Puerto Rico; International: Portugal, Italy, Turkey, Slovakia, Russia, Thailand and Vietnam

## Key facts

- **Recall number:** Z-0285-2018
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-07
- **Report date:** 2018-01-03
- **Termination date:** 2018-07-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crumlin (North), N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0285-2018

## Citation

> AI Analytics. FDA recall Z-0285-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0285-2018. Source: US FDA. Licensed CC0.

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