RTH8 Rotor — Class II medical device recall Z-0857-2015
Terminated recall by Iris Diagnostics, reported 2014-12-31, distributed nationwide. Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifuge because th
| Recall number | Z-0857-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Iris Diagnostics, Chatsworth, CA, United States |
| Recall initiated | 2014-12-03 |
| Classified | 2014-12-23 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2015-11-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CN, CO, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IT, JP, KR, KW, LB, MX, MY, NL, NO, NZ, PT, RO, SE, SK, TH, TR, TW, VE, ZA |
| Quantity | 3,912 units |
| Reason classes | packaging |
| Serial numbers | 3100 |
| Model numbers | M510 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0857-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.