Z-0807-2010

StatSpin Express 4 Horizontal Centrifuge Model # M510

Name: Z-0807-2010 StatSpin Express 4 Horizontal Centrifuge Model # M510
Creator: StatSpin, Inc., dba Iris Sample Processing
Published: 2010-01-27
License: https://open.fda.gov/license/

StatSpin, Inc., dba Iris Sample Processing / initiated 2010-01-27 / Terminated / root cause: design

FDA source

StatSpin, Inc., dba Iris Sample Processing began a recall of StatSpin Express 4 Horizontal Centrifuge Model # M510. Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes on 2010-01-27. The reason FDA records is "Centrifuge shield micro-switch failed due to damage, and the unit opened, ejecting pieces". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0807-2010
Status: Terminated
Initiated: 2010-01-27
Posted: 2010-03-04
Terminated: 2019-11-13
Recalling firm: StatSpin, Inc., dba Iris Sample Processing
Product: StatSpin Express 4 Horizontal Centrifuge Model # M510. Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes.
Product code: JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Reason for recall: Centrifuge shield micro-switch failed due to damage, and the unit opened, ejecting pieces.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 1510 units
Distribution: Worldwide Distribution -- USA, CANADA, AUSTRALIA, JORDAN, UK, BELGIUM, FRANCE, CZECH, RUSSIA, KUWAIT', NORWAY, GREECE, TURKEY, DENMARK, FINLAND, SEOUL, KOREA, and HONG KONG.
Product codes and lots: Serial Numbers: 00100 through 001679.

Product code JQC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)