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U.S. Department of Health and Human Services

Class 2 Device Recall ROTROL P Contorl for ROTEM delta Thromboelastometry System

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 Class 2 Device Recall ROTROL P Contorl for ROTEM delta Thromboelastometry Systemsee related information
Date Initiated by FirmFebruary 18, 2016
Create DateMarch 09, 2016
Recall Status1 Terminated 3 on June 30, 2016
Recall NumberZ-1090-2016
Recall Event ID 73357
510(K)NumberK083842 
Product Classification Plasma, coagulation control - Product Code GGN
ProductROTROL 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.
Code Information Lot 41925401
FEI Number 3008366794
Recalling Firm/
Manufacturer		 TEM Systems Inc
3210 E Nc Hwy 54
Durham NC 27709
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAn 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 in Commerce476 boxes x 5 vials
DistributionDistributed 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GGN
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