Axis-Shield Diagnostics, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
24
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0742-2020Class IIAxis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: TheSeptember 16, 2019
Z-0743-2020Class IIAxis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: ThSeptember 16, 2019
Z-0744-2020Class IIAxis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: TSeptember 16, 2019
Z-1946-2015Class IIAxis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 2March 20, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K253539Alere NT-proBNP for Alinity iFebruary 18, 2026
K241176Alere NT-proBNP for Alinity i Reagent KitJanuary 16, 2025
K233541ARCHITECT Active-B12 (Holotranscobalamin)July 31, 2024
K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayOctober 27, 2017
K121946AXIS-SHIELD ACVTIVE-B12March 22, 2013
K121842ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1CDecember 12, 2012
K112790AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRONMay 7, 2012
K112443ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)December 19, 2011
K110296AXIS-SHIELD ANTI-CCPAugust 18, 2011
K083868ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35September 25, 2009
K083222AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100July 31, 2009
K073640ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLSApril 24, 2008
K072686AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLSMarch 17, 2008
K063347AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10March 20, 2007
K062467AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODELNovember 22, 2006
K041866ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)September 29, 2004
K033606ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TESTJanuary 30, 2004
K031177DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100MJune 19, 2003
K023285DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISAOctober 9, 2002
K021516DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200July 23, 2002