Medica Corporation
FDA Regulatory Profile
Medica Corporation appears in FDA public data with 4 recalls, 7 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1370-2026, Class II) was initiated on December 31, 2025. Its most recent 510(k) clearance was granted on July 26, 2024.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 7
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1370-2026 | Class II | Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit. | December 31, 2025 |
| Z-1294-2019 | Class II | Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer RE | February 6, 2019 |
| Z-1149-2018 | Class II | Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution | November 21, 2017 |
| Z-1267-2018 | Class II | EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of | April 11, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K220328 | EasyStat 300 | July 26, 2024 |
| K220396 | EasyStat 300 | September 26, 2023 |
| K211559 | EasyStat 300 | January 27, 2023 |
| K152327 | EasyLyte Na/K/Cl/Ca Analyzer | December 1, 2016 |
| K130080 | EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MA | May 13, 2014 |
| K123586 | EASYRA CREATININE REAGENT | May 15, 2013 |
| K111036 | EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT | July 12, 2011 |