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U.S. Department of Health and Human Services

Class 2 Device Recall HemosIL ReadiPlasTin

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  Class 2 Device Recall HemosIL ReadiPlasTin see related information
Date Initiated by Firm August 02, 2017
Date Posted March 03, 2018
Recall Status1 Terminated 3 on March 29, 2019
Recall Number Z-0895-2018
Recall Event ID 79165
510(K)Number K122584  
Product Classification Test, time, prothrombin - Product Code GJS
Product Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400

Code Information Lots: N1166235, N0177760, N0278358, N0478057, N0479504 & N0278177.
Recalling Firm/
Instrumentation Laboratory Co.
180 Hartwell Rd
Bedford MA 01730-2443
For Additional Information Contact
Manufacturer Reason
for Recall
Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.
FDA Determined
Cause 2
Under Investigation by firm
Action On August 2, 2017, Instrumentation Laboratory sent an Urgent Medical Device Removal letters dated August 2, 2017 to their customers. On October 5, 2017 Instrumentation Laboratory expanded their recall adding 3 additional lots to a second Urgent Medical Device Removal letter. On February 26, 2018, Instrumentation Laboratory expanded their recall a 3rd time to include 1 additional lot to a third Urgent Medical Device Removal letter. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete a Mandatory Tracking Response form. For questions contact your Customer Service Representative at 1-800-955-9525, option #1.
Quantity in Commerce 14,894 kits
Distribution Worldwide Distribution - US Nationwide
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 = INSTRUMENTATION LABORATORY CO.