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U.S. Department of Health and Human Services

Class 2 Device Recall HemoTrol Level 3

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  Class 2 Device Recall HemoTrol Level 3 see related information
Date Initiated by Firm October 18, 2018
Create Date November 28, 2018
Recall Status1 Terminated 3 on January 07, 2020
Recall Number Z-0515-2019
Recall Event ID 81475
510(K)Number K964052  
Product Classification Control, hemoglobin - Product Code GGM
Product HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture.
Catalogue number: 171.003.002

Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue¿ Hb 201 systems.
Code Information Batch Number: 82467
Recalling Firm/
Manufacturer
EUROTROL INC
850 N Black Branch Rd
Elizabethtown KY 42701
Manufacturer Reason
for Recall
Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
FDA Determined
Cause 2
Material/Component Contamination
Action Eurotrol distributors and initial consignees contacted via e-mail with the recall notification letter on 10/16/18. The recall notification letter sent via overnight mail in case e-mail is not deliverable. The recall notification letter instructs distributors how to perform the subrecall towards end-users and inform Eurotrol about the performed subrecall actions Primary instruction will be to stop using the product (discard according local regulation on medical waste) and contact Eurotrol for replacement material. Questions, contact (Monday through Friday, 9:00 AM to 5:00 PM, Eastern Time): Name: Eurotrol Inc. Address 850 N Black Branch Rd. Zipcode & city: Elizabethtown, KY 42701 USA Phone: T +1 502 501 1180 E-mail: officeusa@eurotrol.com.
Quantity in Commerce 2122
Distribution Worldwide Distribution: US (Nationwide) and countries of: Austria, Australia, Bahrain, France, Hong Kong, Indonesia, Ireland, Japan, Jordan, Kenya, Republic of Korea, Kuwait, Maldives, New Zealand, Mozambique, Pakistan, Poland, Slovenia, Africa, Spain, Thailand, Finland, Norway, and UK.
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 = GGM and Original Applicant = DIRECT SOLUTIONS
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