ROTROL P Control for ROTEM delta Thromboelastometry System — Class II medical device recall Z-1090-2016
Terminated recall by TEM Systems Inc, reported 2016-03-16, distributed in AR, AZ, CA, FL, GA, HI, ID, IL…. Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying th
| Recall number | Z-1090-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TEM Systems Inc, Durham, NC, United States |
| Recall initiated | 2016-02-18 |
| Classified | 2016-03-09 |
| Reported by FDA | 2016-03-16 |
| Terminated | 2016-06-30 |
| Distributed | AR, AZ, CA, FL, GA, HI, ID, IL, IN, LA, MA, MD, MN, MO, NE, NJ, NM, NY, OH, PA, SC, SD, TN, TX, UT, WA, WV |
| Countries outside the US | DE |
| Lot numbers | 41925401 |
Product
ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.
Reason for recall
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.
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-1090-2016. 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.