Recall Z-0515-2019— EUROTROL INC
Class II · Terminated
Class II FDA medical device recall by EUROTROL INC, initiated 2018-10-18, terminated 2020-01-07. It names one FDA 510(k) clearance: K964052. 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.. Reason: Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values.
- Recalling firm
- EUROTROL INC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-10-18
- Terminated
- 2020-01-07
- Firm location
- Elizabethtown, KY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values
Data sourced from openFDA. This site is unofficial and independent of the FDA.