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.
FDA Recall Z-1090-2016 · Posted None
Recalling FirmTEM Systems Inc
Recall StatusTerminated
Product CodeGGN
Date Initiated2016-02-18
Date Terminated2016-06-30
Product Quantity476 boxes x 5 vials
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.
Firm Action
An Urgent Important Customer Information notice was sent to accounts on 2/17/2016. The notice requested that they discontinue use of the product and to contact them for a replacement. The letter also included a response form to be returned.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.