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Terminated

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

FDA Recall Z-2169-2011 · Posted 2011-05-10

Recalling FirmStatSpin, Inc., dba Iris Sample Processing
Recall StatusTerminated
Product CodeJQC
Date Initiated2010-08-18
Date Terminated2020-09-01
Product Quantity2090 units

Reason for Recall

Rotors may fail due to wire spokes breaking

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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