Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ROTROL P Control for ROTEM delta Thromboelastometry System Recalled by TEM Systems Inc Due to Some of vials were found to be partially...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact TEM Systems Inc directly.
Affected Products
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
Quantity: Total 1574 x 5 vials per box
Why Was This Recalled?
Some of vials were found to be partially filled.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About TEM Systems Inc
TEM Systems Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report