Home / Recalls / Medical Devices
EUROTROL INC recalls HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol Hem
Recalled December 5, 2018 · FDA recall Z-0515-2019 · EUROTROL
Hazard
Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values · FDA Class II
Units
2122
Sold at
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.
Description
Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
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.
Manufacturer(s)
EUROTROL INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →