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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 ReadiPlasTinsee related information
Date Initiated by FirmAugust 02, 2017
Date PostedMarch 03, 2018
Recall Status1 Terminated 3 on March 29, 2019
Recall NumberZ-0895-2018
Recall Event ID 79165
510(K)NumberK122584 
Product Classification Test, time, prothrombin - Product Code GJS
ProductHemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
Code Information Lots: N1166235, N0177760, N0278358, N0478057, N0479504 & N0278177.
Recalling Firm/
Manufacturer		 Instrumentation Laboratory Co.
180 Hartwell Rd
Bedford MA 01730-2443
For Additional Information Contact
781-861-4467
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
ActionOn 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 Commerce14,894 kits
DistributionWorldwide Distribution - US Nationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GJS
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