EUROTROL INC recalls HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002.002 Eurotrol HemoLin…

Recall date

October 18, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0514-2019

FDA classification

Class II

Brand / firm

EUROTROL INC

Sold / distributed

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.

Why it was recalled

Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue¿ Hb 201 systems