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U.S. Department of Health and Human Services

Class 2 Device Recall Pacific Hemostasis ThromboplastinDS

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  Class 2 Device Recall Pacific Hemostasis ThromboplastinDS see related information
Date Initiated by Firm October 06, 2010
Create Date June 26, 2015
Recall Status1 Terminated 3 on November 02, 2011
Recall Number Z-1519-2011
Recall Event ID 57107
510(K)Number K940082  
Product Classification Test, time, prothrombin - Product Code GJS
Product Pacific Hemostasis ¿ Thromboplastin-DS, catalog #100354, packaged in 4 mL lypholyzed vials, 10 bottles/carton. Vials are labeled, in part ***Fisher Diagnostics a division of Fisher Scientific Company, LLC Middletown, VA 22645-1905 USA***

Thromboplastin-DS is a Class 2 medical device intended for use in performing the one stage prothrombin time (PT) test and PT-based factor assays.
Code Information V40526, exp 4/2013 V40826, exp 4/2013
Recalling Firm/
Manufacturer		 Fisher Diagnostics, A Company of Fisher Scientific LLC
8365 Valley Pike
Middletown VA 22645-1905
For Additional Information Contact Technical Support
800-528-0494 Ext. 2
Manufacturer Reason
for Recall		 An in vitro diagnostic reagent used in coagulation testing may cause inaccurate clotting times in quality control and patient plasma samples.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, ThermoFisher Scientific, sent two "Urgent Medical Device Removal" letters one via Federal Express on October 20, 2010 and certified mail for domestic customers on October 21, 2010. The letters described the product, problem and action to be taken by the customers. The customers were instructed to indicate the quantities of all affected product currently in stock at their facility; complete and return the attached Response Form/table to Fisher Diagnostics via fax to (540) 869-8129 or by mail to the attention of Technical Support; dispose of any remaining inventory of the affected lot numbers; provide a copy of this letter to their customers, and file this letter for future reference. If you have any questions regarding this notification, please contact our Technical Support staff at 800-528-0494, Option 2, or email techsupport.diagnostics.mtn@themofisher.com.
Quantity in Commerce 1190 kits
Distribution Worldwide distribution: USA including states of: Alaska, Florida, Kentucky, Ohio, New Jersey, New York, and Texas; and countries including: Argentina, Dubai, Italy, Mexico, Philippines, Romania, and Turkey.
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 = GJS and Original Applicant = PACIFIC HEMOSTASIS
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