HemoCue AB
FDA Regulatory Profile
HemoCue AB appears in FDA public data with 5 recalls, 15 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2070-2025, Class II) was initiated on May 12, 2025. Its most recent 510(k) clearance was granted on August 4, 2020.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 15
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2070-2025 | Class II | The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Anal | May 12, 2025 |
| Z-0101-2014 | Class II | HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Swe | July 25, 2013 |
| Z-0086-2014 | Class II | HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitat | July 16, 2013 |
| Z-2190-2013 | Class II | HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose | July 15, 2013 |
| Z-0619-2013 | Class III | Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvet | November 7, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K201217 | HemoCue Hb 301 System | August 4, 2020 |
| K181751 | HemoCue Hb 801 System | February 1, 2019 |
| K071652 | HEMOCUE WBC SYSTEM | October 25, 2007 |
| K060765 | HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE 201 RT MICROCURETTES MDL 110712 | September 6, 2006 |
| K061047 | HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 | June 8, 2006 |
| K053253 | HEMOCUE ALBUMIN 201 ANALYZING SYSTEM | February 17, 2006 |
| K041234 | HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM | June 10, 2004 |
| K041230 | CLINICAL LABORATORY ANALYZING SYSTEM | May 20, 2004 |
| K032203 | HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 | August 25, 2003 |
| K020935 | HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706 | April 3, 2002 |
| K962415 | HEMOCUE B-GLCOSE SYSTEM | October 15, 1996 |
| K961312 | HEMOCUE B-HEMOGLOBIN SYSTEM | September 24, 1996 |
| K961311 | HEMOCUE B-GLUCOSE SYSTEM | August 23, 1996 |
| K943432 | HEMOCUE B-GLUCOSE SYSTEM | January 17, 1995 |
| K911141 | HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER | May 8, 1991 |