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U.S. Department of Health and Human Services

Class 2 Device Recall Instrumentation Labs Test Plasminogen

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  Class 2 Device Recall Instrumentation Labs Test Plasminogen see related information
Date Initiated by Firm December 18, 2015
Date Posted February 01, 2016
Recall Status1 Terminated 3 on August 30, 2017
Recall Number Z-0736-2016
Recall Event ID 72972
510(K)Number K981200  
Product Classification Test, qualitative and quantitative factor deficiency - Product Code GGP
Product HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
Code Information Lot No. N0455811, Expiration Date 03/31/2017
Recalling Firm/
Manufacturer		 Instrumentation Laboratory Co.
180 Hartwell Rd
Bedford MA 01730-2443
For Additional Information Contact Ms. Carol Marble
781-861-4467
Manufacturer Reason
for Recall		 This Lot is not meeting labeled on-board instrument stability claims of 5 days.
FDA Determined
Cause 2		 Device Design
Action Instrumentation Laboratory Co. sent an " Urgent Medical Device Removal" letter dated December 2015, was sent on December 18, 2015. via USPS to US and Canadian customers. The notification requires US and Canadian customers to respond using a Mandatory Response Tracking Form. A Field Safety Notice was e-mailed on December 18, 2015, to the affected IL affiliates, notifying them of the product lot removal due to a stability issue and requesting them to translate the Field Safety Notice, to notify their Competent Authorities and to provide the notification to their affected customer base and secondary distributors. For further questions, please call 1(800) 955-9525.
Quantity in Commerce Domestic: 108 kits, Foreign: 197 kits
Distribution Worldwide Distribution - US Distribution and to the countries of : Canada, Argentina, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, Italy, Lithuania, Panama, Poland, Russia, Saudi Arabia, United Kingdom, and Venezuela.
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 = GGP and Original Applicant = INSTRUMENTATION LABORATORY CO.
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