Recall Z-1090-2016 ยท GGN Plasma, Coagulation Control
TEM Systems Inc
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.
| Date | Feb 18, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 476 boxes x 5 vials |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083842 | ROTEM DELTA THROMBOELASTOMETRY SYSTEM Pentapharm GmbH, Mar 23, 2010 |