Haemoscope Division of Haemonetics Corp
Niles, IL
Haemoscope Division of Haemonetics Corp appears in FDA device records in Niles, IL. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 2
- Registered establishments
- 0
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-2742-2011 | TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 Series Used as the operational check and calibration verification for the TEG 5000 Thrombelastograph Hemostasis Analyzer System | Haemoscope received a report that during the process of Validation, Level II QC was running with an out-of-range low MA (Maximum Amplitude). | Terminated | ||
| Z-1738-2011 | TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL 60714; list number 07-022 a multipurpose system for in vitro coagulation studies | Haemonetics has received a report of smoke from the unit with a power supply failure. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain