| Class 2 Device Recall HemoTrol Level 3 | |
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
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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
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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 |
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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 = GGM
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