FDA-Device2018-12-05Class II
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.
EUROTROL INC
Hazard
Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
Sold states
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.
Affected count
2122
Manufactured in
850 N Black Branch Rd, N/A, Elizabethtown, KY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0515-2019Don't want to check this manually?
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