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Class 2 Device Recall ROTROL P Contorl for ROTEM delta Thromboelastometry System |
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Date Initiated by Firm |
February 18, 2016 |
Create Date |
March 09, 2016 |
Recall Status1 |
Terminated 3 on June 30, 2016 |
Recall Number |
Z-1090-2016 |
Recall Event ID |
73357 |
510(K)Number |
K083842
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Product Classification |
Plasma, coagulation control - Product Code GGN
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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. |
Code Information |
Lot 41925401 |
Recalling Firm/ Manufacturer |
TEM Systems Inc 3210 E Nc Hwy 54 Durham NC 27709
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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.
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FDA Determined Cause 2 |
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 in Commerce |
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. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = GGN and Original Applicant = PENTAPHARM GMBH
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