Iris Diagnostics: Medical Device Recall in 2014 - (Recall #: Z-0857-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.

Product Classification:

Class II

Date Initiated: December 3, 2014

Date Posted: December 31, 2014

Recall Number: Z-0857-2015

Event ID: 69946

Reason for Recall:

Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifuge because the RTH8 rotor may develop cracks with use over time.

Status: Terminated

Product Quantity: 3912 units

Code Information:

Serial No. 3100 through 7012

Distribution Pattern:

Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Venezuela.

Voluntary or Mandated:

Voluntary: Firm initiated