Events

Recall of Device Recall Syva Emit 2000 Theophylline Assay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics, 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
    74524
  • Event Risk Class
    Class 2
  • Event Number
    Z-2299-2016
  • Event Initiated Date
    2016-06-17
  • Event Date Posted
    2016-07-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147834
  • 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
    Enzyme immunoassay, theophylline - Product Code KLS
  • Reason
    Siemens healthcare diagnostics has confirmed the syva¿ emit¿ 2000 theophylline reagent lot g3, when run on a beckman au clinical chemistry system, and the advia¿ chemistry theophylline_2 (theo_2) reagent lot 334018, may exhibit increased imprecision for commercially available bio-rad liquichek tdm quality control levels and patient samples.
  • Action
    Siemens Healthcare Diagnostics mailed a letter to customers on June 17, 2016, asking that they discontinue use of and discard the affected kit lots identified in the recall notification letter. Customers were also asked to complete and return the Field Correction Effectiveness Check/Product Replacement Form that was mailed with the Recall Notification Letter.

Device

Device Recall Syva Emit 2000 Theophylline Assay
  • Model / Serial
    ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent - SMN# 10377503, Lot # 334018
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to: CA, CT, DE, FL, GA, IA, IN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, TN, VA, WA
  • Product Description
    ADVIA¿ Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the quantitative analysis of theophylline in human serum or plasma on the ADVIA¿ Chemistry Systems. || Copies of IFUs included in submission.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA