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U.S. Department of Health and Human Services

Class 2 Device Recall BC Thrombin Reagent

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  Class 2 Device Recall BC Thrombin Reagent see related information
Date Initiated by Firm October 17, 2017
Create Date March 01, 2018
Recall Status1 Terminated 3 on November 04, 2019
Recall Number Z-0827-2018
Recall Event ID 79053
510(K)Number K970645  
Product Classification Test, thrombin time - Product Code GJA
Product BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and
BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time


Product Usage:
For in vitro diagnostic use. Reagent for the quantitative determination of the thrombin time in citrated human plasma.
Code Information Manufactured: BC Thrombin Reagent Kit Lot 46751: 3673 kits BC Thrombin Reagent Kit Lot 47184: 3958 kits  Total kits Distributed to Customers Domestic and Foreign:  BC Thrombin Reagent Kit Lot 46751: 3549 kits BC Thrombin Reagent Kit Lot 47184: 2580 kits  Product Code/ Lot# Date Manufactured Date Expired 46751 2016-11-01 2018-09-08 47184 2017-03-20 2019-02-21   
Recalling Firm/
Manufacturer
Siemens Healthcare Diagnostics
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact Elizabeth Bernasconi
914-524-2495
Manufacturer Reason
for Recall
The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (contains Thrombin Reagent lot 517469) produce unexpected prolonged Thrombin Time (TT) results for expected normal samples, and may recover above the upper limit of normal (< 21 sec.) as stated within the IFU (Instruction For Use).
FDA Determined
Cause 2
Nonconforming Material/Component
Action Siemens sent an Urgent Field Safety Notice letter dated October 2017 to affected customer. The letter identified the affected product, problem and actions to be taken by the customer. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter and the Urgent Field Corrective Action letter within 30 days. For questions contact your Siemens Customers Care Center or local Siemens technical support representative.
Quantity in Commerce 7631 units
Distribution Worldwide distribution. US nationwide, Austria, Belgium, Bosnia-Herzegovina, Croatia, Finland, France (incl. Guadeloupe, Martinique, Reunion, French Guinea overseas departments), Germany, Greece, Hungary, Italy, Kazakhstan, Macedonia, Latvia, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, Sweden, Turkey, Argentina, Brazil, El Salvador, Mexico, Peru, Uruguay, Canada, and Australia.
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 = GJA and Original Applicant = BEHRING DIAGNOSTICS, INC.
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