Events

Recall of Device Recall VerifyNow IIb/IIIa Test, 10Test Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Accumetrics 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
    66834
  • Event Risk Class
    Class 2
  • Event Number
    Z-0482-2014
  • Event Initiated Date
    2013-11-14
  • Event Date Posted
    2013-12-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123688
  • 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
    System, automated platelet aggregation - Product Code JOZ
  • Reason
    Accumetrics is recalling the verifynow iib/iiia 10-test because it contains incorrect information for the amount of time in which to perform the test following collection of the patient sample. the correct instruction is to perform the test within 15 minutes of collecting the patient sample.
  • Action
    Accumetrics sent an Urgent Medical Device Correction letter dated November 14, 2013 to end users for the VerifyNow IIb/IIIa 10-Test. The letter informs the customers of the problems identified and the actions to be taken. The customers are instructed to call Accumetrics Customer Support at (800) 643-1640 option 2 or email at support@accumetrics.com. Customers are instructed to complete and return the enclosed Customer Account Tracking Form as soon as possible. For questions regarding this recall call 858-643-1600.

Device

Device Recall VerifyNow IIb/IIIa Test, 10Test Kit
  • Model / Serial
    Lot No. WC0181H, WC0181J, WC0181K
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including NY, PA, DC, CT, IN, NJ, AR, TX, AZ,and NM.
  • Product Description
    VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, || 10 tests/box; 690 total tests. || The VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow lIb/IlIa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician. The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow lIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide.
  • Manufacturer
    Accumetrics Inc

Manufacturer

Accumetrics Inc
  • Manufacturer Address
    Accumetrics Inc, 3985 Sorrento Valley Blvd Ste B, San Diego CA 92121-1497
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    USFDA