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Terminated

StatSpin Express 4 Horizontal Centrifuge Model # M510. Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes.

FDA Recall Z-0807-2010 · Posted 2010-03-04

Recalling FirmStatSpin, Inc., dba Iris Sample Processing
Recall StatusTerminated
Product CodeJQC
Date Initiated2010-01-27
Date Terminated2019-11-13
Product Quantity1510 units

Reason for Recall

Centrifuge shield micro-switch failed due to damage, and the unit opened, ejecting pieces.

Firm Action

Iris Sample Processing notified distributors by an Urgent Device Recall letter advising of the recall and the defect. Users are to immediately quarantine the affected products and choose between the two options listed in regards to correcting the affected centrifuge. Customers may return the unit or an upgrade kit with instructions will be sent to upgrade the unit. Questions should be directed to Gail Magrath at 800-782-8774 ext. 6123.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution -- USA, CANADA, AUSTRALIA, JORDAN, UK, BELGIUM, FRANCE, CZECH, RUSSIA, KUWAIT', NORWAY, GREECE, TURKEY, DENMARK, FINLAND, SEOUL, KOREA, and HONG KONG.

Official Source

View FDA Recall →

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

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