EUROTROL INC
FDA Regulatory Profile
EUROTROL INC appears in FDA public data with 2 recalls, 7 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0515-2019, Class II) was initiated on October 18, 2018. Its most recent 510(k) clearance was granted on November 15, 2019.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 7
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0515-2019 | Class II | HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003 | October 18, 2018 |
| Z-0514-2019 | Class II | HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002. | October 18, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K192842 | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High | November 15, 2019 |
| K182744 | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High | February 1, 2019 |
| K152553 | CueSee Hypoxic | April 22, 2016 |
| K131595 | EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM | July 26, 2013 |
| K121467 | EUROTROL HEMATOCRIT CONTROL | May 10, 2013 |
| K121468 | EUROTROL GAS-ISE METABOLITES | June 22, 2012 |
| K060215 | ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 | March 24, 2006 |