Device product
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
Z-0514-2019
Product summary
- Firm
- EUROTROL INC
- Event
- Event 81475
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2000
- Official record key
device-enforcement:Z-0514-2019
Official wording
Reason: Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
Code information: Lot Number: 81166
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
microbial contamination