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Recall Observatory FDA recall evidence

Device 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.

Z-0515-2019

October 18, 2018

Class II

Product summary

Firm
EUROTROL INC
Event
Event 81475
Status
Terminated
Classification
Class II
Quantity
2122
Official record key
device-enforcement:Z-0515-2019

Official wording

Reason: Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values

Code information: Batch Number: 82467

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.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    microbial contamination