FDA Device recall Z-0857-2015
RTH8 Rotor, P/N X01-005847-001
- FDA Device
- Class II
- terminated
- Published 2014-12-31
On 2014-12-31 the FDA classified a Class II recall of RTH8 Rotor, P/N X01-005847-001 by Iris Diagnostics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0857-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-03 |
| Published | 2014-12-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Iris Diagnostics |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Serial No. 3100 through 7012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Iris Diagnostics
- iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714…
FDA Device · Class II · 2015-09-02 · Iris Diagnostics - Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12
FDA Device · Class II · 2013-05-22 · Iris Diagnostics - IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074
FDA Device · Class III · 2012-08-08 · Iris Diagnostics
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0857-2015%22
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