Axis-Shield Diagnostics, Ltd.
FDA Regulatory Profile
Axis-Shield Diagnostics, Ltd. appears in FDA public data with 4 recalls, 24 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0742-2020, Class II) was initiated on September 16, 2019. Its most recent 510(k) clearance was granted on February 18, 2026.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 24
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0742-2020 | Class II | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The | September 16, 2019 |
| Z-0743-2020 | Class II | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: Th | September 16, 2019 |
| Z-0744-2020 | Class II | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: T | September 16, 2019 |
| Z-1946-2015 | Class II | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 2 | March 20, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253539 | Alere NT-proBNP for Alinity i | February 18, 2026 |
| K241176 | Alere NT-proBNP for Alinity i Reagent Kit | January 16, 2025 |
| K233541 | ARCHITECT Active-B12 (Holotranscobalamin) | July 31, 2024 |
| K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay | October 27, 2017 |
| K121946 | AXIS-SHIELD ACVTIVE-B12 | March 22, 2013 |
| K121842 | ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C | December 12, 2012 |
| K112790 | AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON | May 7, 2012 |
| K112443 | ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) | December 19, 2011 |
| K110296 | AXIS-SHIELD ANTI-CCP | August 18, 2011 |
| K083868 | ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 | September 25, 2009 |
| K083222 | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 | July 31, 2009 |
| K073640 | ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS | April 24, 2008 |
| K072686 | AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS | March 17, 2008 |
| K063347 | AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 | March 20, 2007 |
| K062467 | AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL | November 22, 2006 |
| K041866 | ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) | September 29, 2004 |
| K033606 | ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST | January 30, 2004 |
| K031177 | DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M | June 19, 2003 |
| K023285 | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA | October 9, 2002 |
| K021516 | DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 | July 23, 2002 |