TEM Systems Inc ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
Brand
TEM Systems Inc
Lot Codes / Batch Numbers
Article number 503-25 (US ROTROL P), Lot no. 41819801, exp date 2016-11 and Lot no. 41855701, exp date 2017-06.
Products Sold
Article number 503-25 (US ROTROL P), Lot no. 41819801, exp date 2016-11 and Lot no. 41855701, exp date 2017-06.
TEM Systems Inc is recalling ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH. due to Some of vials were found to be partially filled.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some of vials were found to be partially filled.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 13, 2026