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
FDA Recall Z-0514-2019 · Posted None
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Recalling FirmEUROTROL INC
Recall StatusTerminated
Product CodeGGM
Date Initiated2018-10-18
Date Terminated2020-01-07
Product Quantity2000
Reason for Recall
Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
Firm 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].
Root Cause
Material/Component Contamination
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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