Z-0515-2019Class II

HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002...

Name: Z-0515-2019 HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002...
Creator: Eurotrol Inc
Published: 2018-10-18
License: https://open.fda.gov/license/

Eurotrol B.V. / initiated 2018-10-18 / Terminated / root cause: manufacturing process

FDA source

EUROTROL INC began a recall of HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol HemoLin is an assayed hemoglobin control... on 2018-10-18. FDA classified it as Class II and gives the reason as "Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0515-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-18
Posted: 2018-11-28
Terminated: 2020-01-07
Recalling firm: Eurotrol B.V.
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.
Product code: GGM Control, Hemoglobin
Reason for recall: Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
Root cause tag: manufacturing process
FDA 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: [email protected].
Quantity in commerce: 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.
Product codes and lots: Batch Number: 82467

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0515-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0514-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-28
Z-0515-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-05	2018-11-28

Product code GGM

K964052Class IIHemocue HemotrolDirect Solutions / cleared 1996-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)