StatSpin, Inc., dba Iris Sample Processing
Westwood, MA
StatSpin, Inc., dba Iris Sample Processing appears in FDA device records in Westwood, MA. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 4
- Registered establishments
- 0
FDA records under these names
1 nameFDA records resolved to StatSpin, Inc., dba Iris Sample Processing carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Iris Sample Processingrecall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2169-2011 | Statspin Express 4 Centrifuge Model Number: SSH4 Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes | Rotors may fail due to wire spokes breaking | Terminated | ||
| Z-0807-2010 | StatSpin Express 4 Horizontal Centrifuge Model # M510. Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes. | Centrifuge shield micro-switch failed due to damage, and the unit opened, ejecting pieces. | Terminated | ||
| Z-2234-2008 | StatSampler 200 uL, Li Heparin (micro blood collector) Ref: SS2H Packed in Catalog Numbers: SS2H (I vial), SS2H-06 (6 kits/case), CH2C-I0 (I0 vials/kit) Intended for collection and processing of capillary blood to prepare plasma/serum. | EDTA inadvertently mixed with lithium heparin solution contained in capillary tubes. | Terminated | ||
| Z-0198-2007 | StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502 | Rotor may crack and separate causing device to fail. A failed rotor not successfully contained may seriously injure the laboratory worker. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain