Events

Recall of Accriva Diagnostic Inc. Activated Partial Thromboplastin Time cuvettes

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

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
    73949
  • Event Risk Class
    Class 2
  • Event Number
    Z-1720-2016
  • Event Initiated Date
    2016-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145590
  • 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, multipurpose for in vitro coagulation studies - Product Code JPA
  • Reason
    Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing aptt test to either have an error code or an erroneously high result.
  • Action
    Accriva sent an " Urgent Field Safety Notice" letter dated April 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to take the following actions: 1. Forward communication to all those within organization who need to be aware of this matter. In addition, forward notification to all other organizations where affected devices may have been transferred to. 2. Check inventory to determine if you have any APTT Test Cuvettes, Lot Number: B6JCA012 3. If have inventory of APTT Test Cuvettes, with the subject Lot Number destroy the product and submit the attached Destruction Form along with your request for credit. 4. If have inventory DO NOT SHIP TO CUSTOMERS any kits labeled with APTT Test Cuvettes and the subject Lot Number. 5. If have shipped this product to customers please inform them immediately to STOP using the product. Provide the customers with a copy of this notification, request for the destruction of any unused product and the return of the attached forms. 6. Follow the instructions on the attached Field Corrective Action Form, complete the form and return it as instructed on the form. 7. If have questions, please contact Accriva Diagnostics directly contact information is provided below. Accriva Diagnostic, Attn: Regulatory Affairs USA Tel: 858.263.2347 Email: Fieldaction16-007@accriva.com

Device

Accriva Diagnostic Inc. Activated Partial Thromboplastin Time cuvettes
  • Model / Serial
    Lot #B6JCA012
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany.
  • Product Description
    Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
  • Manufacturer
    Accriva Diagnostics Inc., dba ITC, dba Accumetrics

Manufacturer

Accriva Diagnostics Inc., dba ITC, dba Accumetrics
  • Manufacturer Address
    Accriva Diagnostics Inc., dba ITC, dba Accumetrics, 6260 Sequence Dr, San Diego CA 92121-4358
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    USFDA