FDA Medical Device Recalls (openFDA)
EUROTROL INC: 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.
- Recall number
- Z-0515-2019
- Recalling firm
- EUROTROL INC
- 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.
- Status
- Terminated
- Initiated
- 2018-10-18
- Posted
- not on file
- Terminated
- 2020-01-07
- Reason
- Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
- Root cause
- Material/Component Contamination
- Action
- Eurotrol distributors and initial consignees contacted via e-mail with the recall notification letter on 10/16/18. The recall notification letter sent via overnight mail in case e-mail is not deliverable. The recall notification letter instructs distributors how to perform the subrecall towards end-users and inform Eurotrol about the performed subrecall actions Primary instruction will be to stop using the product (discard according local regulation on medical waste) and contact Eurotrol for replacement material. Questions, contact (Monday through Friday, 9:00 AM to 5:00 PM, Eastern Time): Name: Eurotrol Inc. Address 850 N Black Branch Rd. Zipcode & city: Elizabethtown, KY 42701 USA Phone: T +1 502 501 1180 E-mail: officeusa@eurotrol.com.
- Quantity
- 2122
- 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.
- Lot, serial or model codes
- Batch Number: 82467
- 510(k) numbers
- ["K964052"]
- PMA numbers
- not on file
- Product code
- GGM
- Firm FEI
- 3005837764
- Firm city
- Elizabethtown
- Firm state
- KY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28