Z-0198-2007

StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502

Name: Z-0198-2007 StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502
Creator: Iris Sample Processing
Published: 2006-09-29
License: https://open.fda.gov/license/

StatSpin, Inc., dba Iris Sample Processing / initiated 2006-09-29 / Terminated

FDA source

Iris Sample Processing began a recall of StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502 on 2006-09-29. The reason FDA records is "Rotor may crack and separate causing device to fail. A failed rotor not successfully contained may seriously injure the laboratory worker". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0198-2007
Status: Terminated
Initiated: 2006-09-29
Posted: 2006-11-21
Terminated: 2006-12-13
Recalling firm: StatSpin, Inc., dba Iris Sample Processing
Product: StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502
Product code: JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Reason for recall: Rotor may crack and separate causing device to fail. A failed rotor not successfully contained may seriously injure the laboratory worker.
FDA root cause: Other
Action: Iris telephoned customers on 9/29/06 and advised them of the recall of the rotor. New rotors were mailed Overnight Confirmed Delivery with instructions for replacement and return of the the old rotor.
Quantity in commerce: 94 units (Revised on 11/15/06 to 116 units)
Distribution: Nationwide
Product codes and lots: Rotors with serial numbers: B1562 to B1738

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)