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Class 2 Device Recall HemosIL ReadiPlasTin |
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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
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Product Classification |
Test, time, prothrombin - Product Code GJS
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Product |
Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
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Code Information |
Lots: N1166235, N0177760, N0278358, N0478057, N0479504 & N0278177. |
Recalling Firm/ Manufacturer |
Instrumentation Laboratory Co. 180 Hartwell Rd Bedford MA 01730-2443
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For Additional Information Contact |
781-861-4467
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = GJS and Original Applicant = INSTRUMENTATION LABORATORY CO.
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