Axis-Shield Diagnostics, Ltd.

• CDD — Clinical Chemistry5 devices
• NHX — Immunology5 devices
• JZO — Immunology3 devices
• LPS — Clinical Chemistry3 devices
• NBC — Clinical Chemistry3 devices
• LCP — Hematology2 devices
• CDZ — Clinical Chemistry1 device
• MID — Immunology1 device
• MSV — Immunology1 device

• Z-0742-2020 — Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.Class II·Ongoing·2019-09-16
• Z-0743-2020 — Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.Class II·Ongoing·2019-09-16
• Z-0744-2020 — Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.Class II·Ongoing·2019-09-16
• Z-1946-2015 — Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.Class II·Terminated·2015-03-20

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K253539 — Alere NT-proBNP for Alinity iCode NBC·2026-02-18
• K241176 — Alere NT-proBNP for Alinity i Reagent KitCode NBC·2025-01-16
• K233541 — ARCHITECT Active-B12 (Holotranscobalamin)Code CDD·2024-07-31
• K172133 — ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayCode CDD·2017-10-27
• K121946 — AXIS-SHIELD ACVTIVE-B12Code CDD·2013-03-22
• K121842 — ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1CCode LCP·2012-12-12
• K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRONCode LPS·2012-05-07
• K112443 — ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)Code CDD·2011-12-19
• K110296 — AXIS-SHIELD ANTI-CCPCode NHX·2011-08-18
• K083868 — ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35Code NHX·2009-09-25
• K083222 — AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100Code LPS·2009-07-31
• K073640 — ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLSCode LPS·2008-04-24
• K072686 — AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLSCode LCP·2008-03-17
• K063347 — AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10Code NHX·2007-03-20
• K062467 — AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10Code CDD·2006-11-22
• K041866 — ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)Code CDZ·2004-09-29
• K033606 — ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TESTCode NBC·2004-01-30
• K031177 — DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100MCode MSV·2003-06-19
• K023285 — DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISACode NHX·2002-10-09
• K021516 — DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200Code NHX·2002-07-23
• K020348 — ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORSCode JZO·2002-05-02
• K020349 — ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORSCode JZO·2002-05-02
• K020687 — DIASTAT ANTI-THYROID PEROXIDASE ELISA MODEL #300Code JZO·2002-05-02
• K020156 — DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100TCode MID·2002-03-06