Events

Recall of Device Recall DIASTAT AntiCCP test kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Axis-Shield Diagnostics, 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
    36018
  • Event Risk Class
    Class 3
  • Event Number
    Z-0003-2007
  • Event Initiated Date
    2005-11-11
  • Event Date Posted
    2006-10-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-03-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47623
  • 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
    Anti-CCP kit - Product Code NHX
  • Reason
    The preservative sodium azide used in the kit negative control (part number fcom175) was at the wrong concentration - the kit negative control contains 0.2% sodium azide rather than the intended 0.1%.
  • Action
    Advisory letter was sent to customers informing them of the increased sodium azide content. A specific letter was sent to each customer / distributor informing them of the misformulation. The content of the letter referred to the specific kits received by each customer. The letter informed users about the additional risk relating to double azide concentration. The outcome of the risk evaluation was as follows: 1) There is no impact to product performance and hence patient results because of this. 2) The increase in the sodium azide concentration changes the hazard status from ''No significant hazard'' to ''Harmful'', with the following additional risk phrases R22 (harmful if swallowed) and R32 (contact with acids liberates toxic gas). The accompanying safety phrases are S23 (do not breathe fumes), S26 (in case of contact with eyes, rinse immediately with plenty of water and seek medical advice), S46 (if swallowed, seek medical advice immediately and show this container or label) and S61 (avoid release to environment, refer to special instructions/safety data sheets). 3) The risk of the increase in sodium azide concentration in the Kit Negative Conrol to the end user is deemed to be minimal due to the low volume of the Negative Control. The letter states that the product can still be safely used and users should be aware of and take notice of the advisory letter.

Device

Device Recall DIASTAT AntiCCP test kit
  • Model / Serial
    The kit lots have the following lot numbers: 052534, 052592, 052296, 052536 (expiration date of 2007-02-09);and 052106 (exp. date 2006-08-09), and with storage requirements at between 2-8¿C. The nonconforming kit compoinent is the Negative Control (labeled ''CONTROL --''). There are two Negative Control lots affected. Both have the same expiration date of 2007-02-21 with one lot number being Ch.-B.502186301 (for kit lots 052534 and 052106) and the other lot number being Ch.-B.502186302 (for kit lots 052592, 052296 and 052536).
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution ---- USA including states of MN, CA, NJ, WA, IL, CO,and NY and countries of Canada, Spain, Bulgaria, UK, Lebanon, Russia, Columbia, South Africa, Italy, Sweden, Germany, Norway, Venezuela, Japan, Tunisia, Cyprus, The Netherlands, Greece, Israel, and India.
  • Product Description
    Axis-Shield DIASTAT Anti-CCP test kit, (code FCCP200)
  • Manufacturer
    Axis-Shield Diagnostics, Ltd.

Manufacturer

Axis-Shield Diagnostics, Ltd.
  • Manufacturer Address
    Axis-Shield Diagnostics, Ltd., The Technology Park, Luna Place, Dundee, Scotland United Kingdom
  • Source
    USFDA