Events

Recall of Device Recall N Latex HCY

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
    76251
  • Event Risk Class
    Class 2
  • Event Number
    Z-1227-2017
  • Event Initiated Date
    2017-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152588
  • 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
    Urinary homocystine (nonquantitative) test system - Product Code LPS
  • Reason
    The firm confirmed a reduced once-opened and on-board stability for n latex homocysteine (hcy) opax03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values. the stability issue may lead to higher than expected lot-to-lot variation and an impaired product performance.
  • Action
    URGENT MEDICAL DEVICE RECALL Letter (PP17-005.A.US, dated 1/11/2016) was sent to the sole US consignee via FedEx on 1/11/2017 to notify the customer of the issue. All N Latex HCY OPAX03 lot 802907632 customers are being instructed to discard N Latex HCY OPAX03 lot 802907632. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the UMDR within 30 days. On 1/13/2017, an URGENT MEDICAL DEVICE RECALL letter (PP17-005.B.US, dated 1/13/2017) was sent to the sole US consignee with instructions to discontinue use of and discard the kit lot; complete & return the Field Correction Effectiveness Check/Product Replacement Form attached to this letter within 30 days; Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. For questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.

Device

Device Recall N Latex HCY
  • Model / Serial
    Lot 802907632, Exp. 2017-02-13
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the state of Colorado and Foreign distribution to the following countries: Austria, Brazil, Canary Islands, Chile, China, Czech Republic, France, Germany, Great Britain (UK), Italy, Kuwait, Latvia, Poland, Saudi Arabia, Spain, Switzerland, Turkey, United Arab Emirates.
  • Product Description
    N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD || Product Usage: || In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA