Events

Recall of Device Recall VITROS Chemistry Products VANC Reagent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ortho-Clinical Diagnostics.

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
    76551
  • Event Risk Class
    Class 2
  • Event Number
    Z-1887-2017
  • Event Initiated Date
    2017-02-21
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153500
  • 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
    Radioimmunoassay, vancomycin - Product Code LEH
  • Reason
    Potential for biased results generated using the specific lots of vitros vanc reagent. this can occur after the reagent packs are loaded onto the analyzer and stored within the on-analyzer stability date.
  • Action
    Ortho Clinical Diagnostics sent an IMPORTANT PRODUCT CORRECTION NOTIFICATION letter dated February 21, 2017, was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all customers who received the affected VITROS Chemistry Products VANC Reagent lots to inform them of the potential for biased results and to request that they immediately discontinue use of this product. Foreign affiliates were informed by e-mail on February 21, 2017, of the issue and instructed to notify their consignees of the affected product with this issue and the requirement to immediately discontinue use of the product. The communication instructed customer to immediately discontinue use of the affected product. In order to minimize the disruption to the laboratory, the communication also provided the instructions for testing using the affected VANC lots until replacement product was received. If you have any further questions, please contact our OrthoCare Technical Solutions Ctr. at 1(800) 421-3311. For further questions regarding this recall, please call (908) 218-8776.

Device

Device Recall VITROS Chemistry Products VANC Reagent
  • Model / Serial
    Lot numbers: 31-5407 (exp. date 2017-05-23), 31-5474 (exp. date 2017-07-04), 31-5506 (exp. date 2017-07-04)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Spain Singapore and Venezuela.
  • Product Description
    VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a maximum on-analyzer stability of < 7days. The on-analyzer stability of each VITROS VANC Reagent pack is determined by the system. Once the VANC reagent pack is loaded on the system, the on-analyzer stability time is continuously adjusted based upon both the amount of time the reagent pack is on the analyzer and the number of tests remaining in the pack. The method by which the on-analyzer stability of the VITROS VANC Reagent is determined is stated in the reagents Instructions for Use.
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Address
    Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
  • Manufacturer Parent Company (2017)
    The Carlyle Group LP
  • Source
    USFDA