Events

Recall of Centrifuge Model CF-6 with lid lock. (Block Model Number OCT-VI).

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cygnus LLC.

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
    34386
  • Event Risk Class
    Class 3
  • Event Number
    Z-0564-06
  • Event Initiated Date
    2005-09-08
  • Event Date Posted
    2006-02-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43754
  • 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
    Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use - Product Code JQC
  • Reason
    When device was packaged, too much expanding foam was added causing the lid to deform and causing the lid locking mechanism to be out of alignment.
  • Action
    A recall notice was sent to Bloch Scientific on September 8, 2005. Bloch further distributed the product to MTF, Cascade and will conduct a sub-recall

Device

Centrifuge Model CF-6 with lid lock. (Block Model Number OCT-VI).
  • Model / Serial
    Serial Numbers: Labeled for MFT --  033824; 033825; 033827 through 033840; 033842 through 033844; 033852 through 033855; 033857 through 033863; 034411 through 034415; 034417 through 034445; 08296594 through 08296608.  Labeled for Cascade --  033690; 033989; 034109; 033942 through 033956; 033958 through 033960; 034119 through 034128.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    All product was shipped domestically to the firm''s distributor: Block Scientific, 1170 Lincoln Ave., Unit 11, Holbrook, NY 11741
  • Product Description
    Centrifuge Model CF-6 with lid lock. (Block Model Number OCT-VI). Units are distributed to Bloch Scientific, Holbrook, NY for Bloch''s customers MFT and Cascade.
  • Manufacturer
    Cygnus LLC

Manufacturer

Cygnus LLC
  • Manufacturer Address
    Cygnus LLC, 510 E 41st St, Paterson NJ 07504-1210
  • Source
    USFDA