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 Customer complaints about failed target ranges for alpha...
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, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.
Quantity: 476 boxes x 5 vials
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 27 states: AZ, AR, CA, FL, GA, HI, ID, IL, IN, LA, MD, MA, MN, MO, NE, NJ, NM, NY, OH, PA, SC, SD, TN, TX, UT, WA, WV
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