HemoTrol Level 3- In Vitro Diagnostic Hematology quality control… — Class II medical device recall Z-0515-2019
Terminated recall by EUROTROL INC, reported 2018-12-05, distributed nationwide. Incorrect measurement results caused by microbial contamination of the product, results in values lower than a
| Recall number | Z-0515-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | EUROTROL INC, Elizabethtown, KY, United States |
| Recall initiated | 2018-10-18 |
| Classified | 2018-11-28 |
| Reported by FDA | 2018-12-05 |
| Terminated | 2020-01-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BH, ES, FI, FR, GB, HK, ID, IE, JO, JP, KE, KR, KW, NO, NZ, PK, PL, SI, TH |
| Quantity | 2,122 |
| Reason classes | microbial contamination |
| Lot numbers | 82467 |
| Model numbers | 171.003.002 |
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.
Reason for recall
Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0515-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.