Events

Recall of Device Recall HbA1c

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Randox Laboratories Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77611
  • Event Risk Class
    Class 2
  • Event Number
    Z-0285-2018
  • Event Initiated Date
    2017-06-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156814
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Assay, glycosylated hemoglobin - Product Code LCP
  • 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.
  • Action
    Randox Laboratories sent an Urgent Field Safety Notice dated June 6, 2017, sent to all global consignees on June 7, 2017, via e-mail. This includes the sole US consignee. Customers are advised to dispose of any existing stock and to contact technical support with respect to reimbursement for loss of material. The company will follow up every 2 weeks over a six week period with the consignees. For further questions, please call (304) 728-2890.

Device

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.

Manufacturer

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