FDA Device recall Z-0302-2017
ex-TEM Assay for ROTEM delta Thromboelastometry System
- FDA Device
- Class II
- terminated
- Published 2016-11-02
On 2016-11-02 the FDA classified a Class II recall of ex-TEM Assay for ROTEM delta Thromboelastometry System by Tem Systems, citing customers complained of low/empty reagent vials.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0302-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-13 |
| Published | 2016-11-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tem Systems |
| Distribution | US |
Product
ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.
Reason
Customers complained of low/empty reagent vials.
Identifiers
| code_info | Lot No. 21929007 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0302-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.