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U.S. Department of Health and Human Services

Class 2 Device Recall exTEM Assay for the ROTEM delta Thromboelastometry System

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  Class 2 Device Recall exTEM Assay for the ROTEM delta Thromboelastometry System see related information
Date Initiated by Firm September 13, 2016
Create Date October 23, 2016
Recall Status1 Terminated 3 on December 05, 2017
Recall Number Z-0302-2017
Recall Event ID 75265
510(K)Number K101533  
Product Classification System, multipurpose for in vitro coagulation studies - Product Code JPA
Product ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem.

Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.
Code Information Lot No. 21929007
Recalling Firm/
Manufacturer		 TEM Systems Inc
3210 E Nc Hwy 54
Durham NC 27709
For Additional Information Contact Rick Epps
919-941-7777 Ext. 108
Manufacturer Reason
for Recall		 Customers complained of low/empty reagent vials.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Customers were notified of the recall by an Urgent Important Customer Information letter on 9/13/2016. The letter described the device and the problem. Customers were told to stop using the product and to call for replacement product. The letter included a Confirmation of Compliance Letter which was to be completed and returned.
Quantity in Commerce 637 boxes x 10 vials
Distribution Nationwide Distribution -- AR, CA, DC, GA, HI, ID, IL, IN, LA, ME, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, and WV.
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 = Tem Innovations GmbH
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