FDA Medical Device Recalls (openFDA)
Iris Sample Processing: StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502
- Recall number
- Z-0198-2007
- Recalling firm
- Iris Sample Processing
- Product
- StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502
- Status
- Terminated
- Initiated
- 2006-09-29
- Posted
- 2006-11-21
- Terminated
- 2006-12-13
- Reason
- Rotor may crack and separate causing device to fail. A failed rotor not successfully contained may seriously injure the laboratory worker.
- 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
- 94 units (Revised on 11/15/06 to 116 units)
- Distribution
- Nationwide
- Lot, serial or model codes
- Rotors with serial numbers: B1562 to B1738
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQC
- Firm FEI
- 1221015
- Firm city
- Westwood
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28