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TEM Systems Inc recalls ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material
Recalled March 16, 2016 · FDA recall Z-1090-2016 · TEM Systems
Hazard
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. · FDA Class II
Units
476 boxes x 5 vials
Sold at
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.
Description
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.
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.
Manufacturer(s)
TEM Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →