FDA Device recall Z-1090-2016
ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only
- FDA Device
- Class II
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class II recall of ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only by Tem Systems, citing 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 20….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1090-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-18 |
| Published | 2016-03-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tem Systems |
| Distribution | 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 |
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
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.
Identifiers
| code_info | Lot 41925401 |
|---|
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-1090-2016%22
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