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U.S. Department of Health and Human Services

Class 2 Device Recall ROTROL P

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  Class 2 Device Recall ROTROL P see related information
Date Initiated by Firm October 23, 2014
Date Posted April 03, 2015
Recall Status1 Terminated 3 on August 13, 2015
Recall Number Z-1379-2015
Recall Event ID 70690
510(K)Number K083842  K101533  
Product Classification System, multipurpose for in vitro coagulation studies - Product Code JPA
Product ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
Code Information Article number 503-25 (US ROTROL P), Lot no. 41819801, exp date 2016-11 and Lot no. 41855701, exp date 2017-06.
Recalling Firm/
TEM Systems Inc
4309 Emperor Blvd Ste 100
Durham NC 27703-8069
For Additional Information Contact Rick Epps
919-941-7777 Ext. 108
Manufacturer Reason
for Recall
Some of vials were found to be partially filled.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Tem sent an Dear Customer letter dated October 23, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. You are entitled to return products delivered to you in the event that they are defective or otherwise not in conformity with your order when you received them. If you observe a low level of diluent in a box of Rotrol P lot number 41819801 at your location, please contact us for a free of charge replacement box from a new lot of Rotrol P. You can reach us at: Email: support@roteminc.com Phone: 919-941-7777, Option 2 Toll Free: 1-866-597-1652, Option 2 We apologize for any inconvenience you may experience.
Quantity in Commerce Total 1574 x 5 vials per box
Distribution Nationwide Distribution
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JPA and Original Applicant = PENTAPHARM GMBH
510(K)s with Product Code = JPA and Original Applicant = Tem Innovations GmbH