Events

Recall of Device Recall TinaQuant (Latex) HS Test System (CReactive Protein (Latex) High Sensitive)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diagnostics Operations, Inc..

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
    75711
  • Event Risk Class
    Class 2
  • Event Number
    Z-1092-2017
  • Event Initiated Date
    2016-02-26
  • Event Date Posted
    2017-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151085
  • 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
    Cardiac c-reactive protein, antigen, antiserum, and control - Product Code NQD
  • Reason
    Tina-quant cardiac c-reactive protein (latex) high sensitive (crphs) lot number 604450 (catalog number 11972855216) shows an under-recovery of up to -25% at concentrations below 5 mg/l on the modular analytics p module. this issue can lead to erroneous low crphs results. crphs is used as a marker for the prediction of cardiovascular risk. an erroneous low result could lead to an incorrect cardiovascular risk assessment and subsequent delay of further examination.
  • Action
    Roche Diagnostics sent a Reagent Bulletin dated February 26, 2016, to all affected consignees. The recall notifications included a description of the reason for the recall, affected product, request for replacement, and consignee responsibilities; the notification did not include instructions for responding to the recall notification. Actions Required " Do not use CRPHS lot number 604450. If you have any affected product in your inventory, discard it per local guidelines. " Complete the attached replacement request form to receive replacement product. " File this Reagent Bulletin for future reference. Questions Please contact the Roche Support Network Customer Support Center at 1-800-428-2336 if you have questions about the information contained in this Reagent Bulletin.

Device

Device Recall TinaQuant (Latex) HS Test System (CReactive Protein (Latex) High Sensitive)
  • Model / Serial
    Catalog number: 11972855216, lot number 60445001
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AL, AZ, CA, CT, FL, GA, KS, MA, MO, NJ, NY, PA, and WA.
  • Product Description
    Tina-Quant (Latex) HS Test System || (C-Reactive Protein (Latex) High Sensitive) || The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. Highly sensitive measurement of CRP is of use for the detection and evaluation of inflammatory disorders, and associated diseases, infection and tissue injury. Measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Manufacturer Address
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    USFDA