Z-1090-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 16, 2016
- Initiation Date
- February 18, 2016
- Termination Date
- June 30, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 476 boxes x 5 vials
Product Description
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.
Distribution Pattern
Distributed in the states of AZ, AR, CA, FL, GA, HI, ID, IL, IN, LA, MD, MA, MN, MO, NE, NJ, NM, NY, PA, OH, SC, SD, TN, TX, UT, WA, WV and the country of Germany.
Code Information
Lot 41925401