Class 2 Device Recall HemosIL ReadiPlasTin

• Date Initiated by Firm: August 01, 2018
• Create Date: October 05, 2018
• Recall Status: Terminated on April 16, 2019
• Recall Number: Z-0077-2019
• Recall Event ID: 80932
• 510(K)Number: K122584
• Product Classification: Test, time, prothrombin - Product Code GJS
• Product: Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
• Code Information: Lot Number - N0278177 Exp. Date February 28, 2019
• Recalling Firm/ Manufacturer: Instrumentation Laboratory Co.; 180 Hartwell Rd; Bedford MA 01730-2443
• For Additional Information Contact: 800-955-9525 Ext. 1
• Manufacturer Reason for Recall: There is a potential for increased imprecision, out of range quality controls and prolonged sample results.
• FDA Determined Cause: Material/Component Contamination
• Action: On August 1, 2018, Instrumentation Laboratory issued Urgent Medical Device Removal and Field Safety notices to their customers. Customers were advised to take the following actions: - Run quality controls with each vial and a minimum of every 8 hours per labeled insert instructions to identify possible vials with the above performance issues until an alternative product lot of HemosIL ReadiPlasTin or an alternative PT reagent has been received and is ready for use. NOTE: ACL TOP Family and ACL TOP Family 50 Series analyzers can be configured to automatically perform QC at vial change. Reference "Before vial use" under the QC Setup Definition section of the On-line Help or contact your IL representative for assistance. - Discard any vial with failed quality controls. Only use vials where all quality controls are in range. - Check your inventory for Lot No. N0278177 and add instructions (copy of the notice) to run quality controls with each vial. - Contact your local representative to convert to an alternative product lot of HemosIL ReadiPlasTin or an alternative PT reagent. - Verify the alternative lot immediately on receipt and then destroy any unused boxes of Lot No. N0278177. - Document the destruction on the Mandatory Tracking Response Record and return the completed and signed form to IL Regulatory either via fax to 781-861-4207 or via email to ra-usa@ilww.com. - Share the information with all laboratory staff and follow your internal procedures. - Forward the notification to all affected locations within your facility. - Retain a copy of the notification for your records.
• Quantity in Commerce: 9751 kits
• 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.