ROTEM® delta System (US/CA)
ROTEM® delta System (US/CA) (201001) is a Class II device made by Tem Innovations GmbH, cleared under FDA 510(k) K083842 on 23 Mar 2010 and listed in FDA GUDID since 15 Mar 2018 (UDI-DI 04260160470587), active as of 23 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04260160470587 | Date15 Mar 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK083842 | Date23 Mar 2010 | StatusActive |
Official records
- AccessGUDID record 04260160470587
- FDA 510(k) database K083842
Across registries
- FDA 510(k) K083842 decided 23 Mar 2010 Active
- FDA GUDID UDI-DI 04260160470587 listed 15 Mar 2018 Listed
Recalls
-
- Terminated Z-1090-2016
Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm is July 2016.
-
- Terminated Z-1379-2015
Some of vials were found to be partially filled.
Timeline
- Cleared FDA 510(k) K083842
- Recall initiated FDA recalls Z-1379-2015
- Recall initiated FDA recalls Z-1090-2016
- Listed FDA GUDID 04260160470587
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Rotem®
- Generic name
- Coagulation analyser IVD, laboratory, semi-automated
- Model / Ref / Catalog
- delta System (US/CA), 201001
- Primary DI / UDI-DI
- 04260160470587
- 510(k) Number
- FDA product code
- GGN, JPA
- GMDN term
- Coagulation analyser IVD, laboratory, semi-automated
- Device class
- Class II
- Regulation number
- 864.5425
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under FDA product code GGN (Plasma, Coagulation Control).
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- LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 by Bio-Rad
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