EUROTROL INC: Medical Device Recall in 2018 - (Recall #: Z-0515-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 18, 2018

Date Posted: December 5, 2018

Recall Number: Z-0515-2019

Event ID: 81475

Reason for Recall:

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

Status: Terminated

Product Quantity: 2122

Code Information:

Batch Number: 82467

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated