ROTROL P Control for ROTEM delta Thromboelastometry System — Class II medical device recall Z-1379-2015
Terminated recall by TEM Systems Inc, reported 2015-04-15, distributed nationwide. Some of vials were found to be partially filled.
| Recall number | Z-1379-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TEM Systems Inc, Durham, NC, United States |
| Recall initiated | 2014-10-23 |
| Classified | 2015-04-03 |
| Reported by FDA | 2015-04-15 |
| Terminated | 2015-08-13 |
| Distributed | Nationwide (US) |
| Lot numbers | 2016-11, 2017-06, 41819801, 41855701 |
Product
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
Reason for recall
Some of vials were found to be partially filled.
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-1379-2015. 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.