Statspin Express 4 Centrifuge Model Number: SSH4 Intended Use: Rapid Separation of plasma and serum from primary gel col

FDA device recall Z-2169-2011 · posted 2011-05-10 · Terminated

Recall details

Recalling firm

StatSpin, Inc., dba Iris Sample Processing

Reason for recall

Rotors may fail due to wire spokes breaking

Action taken

Iris notified customers by letter in August 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to install the new rotors and discard the older rotors with the wires. There was no need for customers to return the rotors, but the firm requested customers fax or e-mail the enclosed form to verify that they have installed the new rotors. For any questions customers should call 1-800-782-8774.

Root cause

Device Design

Status

Terminated

Product code

JQC

Quantity affected

2090 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia Belgium, Czech Republic, Finland, France, Greece, Kuwait, Norway, Turkey,UK, and Norway.

Date initiated

2010-08-18

Date posted

2011-05-10

Date terminated

2020-09-01

Location

Westwood, MA