Class II — EUROTROL INC
| Recalling firm | EUROTROL B.V. |
|---|---|
| Registered facility | EUROTROL B.V. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values |
| Product | 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 |
| Quantity | 2000 |
| 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. |
| Initiated | 2018-10-18 |
| Classified | 2018-11-28 |
| Terminated | 2020-01-07 |
| Recall number | Z-0514-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — EUROTROL INC (Z-0514-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81475/
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