ex-TEM Assay for ROTEM delta Thromboelastometry System — Class II medical device recall Z-0302-2017
Terminated recall by TEM Systems Inc, reported 2016-11-02, distributed nationwide. Customers complained of low/empty reagent vials.
| Recall number | Z-0302-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TEM Systems Inc, Durham, NC, United States |
| Recall initiated | 2016-09-13 |
| Classified | 2016-10-23 |
| Reported by FDA | 2016-11-02 |
| Terminated | 2017-12-05 |
| Distributed | Nationwide (US) |
| Lot numbers | 21929007 |
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 for recall
Customers complained of low/empty reagent vials.
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-0302-2017. 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.