1,715 results
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Sources: EU EUDAMED, US FDA
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ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code CGN·July 25, 2013
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023
IMx Folate Ion Capture Component Set, list 2220-88; the set consists of 1 IMx Folate Reagent Pack, 100 tests, list 2220-20, and 100 Ion Capture reaction cells; Abbott Laboratories, Abbott Park, IL 60064 USA
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·December 16, 2003
ARCHITECT Folate Manual Diluent, List 6C12-50; One 4 mL bottle of ARCHITECT Folate Manual Diluent containing TRIS buffer with protein stabilizer; Abbott Laboratories, Abbott Park, IL 60064 USA
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·December 16, 2003
ARCHITECT Folate High Controls, List 6C12-11; the kit contains 8 - 1 mL vials of High Control H 15.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·December 16, 2003
Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CGN·January 9, 2023
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code CGN·July 3, 2024
Folate Low and High Controls, list 9C13-10; the pack contains 8 - 2 mL bottles( 4 for each level), Low Control L 2.5 ng/mL and High Control H 15.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·December 16, 2003
AxSYM Folate RBC Protein Diluent Pack, list 3C81-65; one 13 mL bottle contains human albumin; Abbott Laboratories, Abbott Park, IL 60064 USA
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·December 16, 2003
IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture Reaction Cells) and list 2220-20 (100 tests - reagents alone); Abbott Laboratories, Abbott Park, IL 60064 USA
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·November 23, 2003
ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code CGN·July 27, 2015
AxSYM Folate Medium Control Pack , list 3C81-11, the pack contains 8 - 1 mL vials of Medium Control M 7.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·December 16, 2003
IMx Specimen Diluent Pack, list 2220-50; 1 - 10 mL bottle containing TRIS buffer with human albumin; Abbott Laboratories, Abbott Park, IL 60064 USA
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·December 16, 2003
ARCHITECT Folate Reagent Kit, list 6C12-20 ( 4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests), Abbott Laboratories, Abbott Park, IL 600064 U.S.A.
FDA Recall
Terminated
·Abbott Laboratories MPG·Product code CGN·March 11, 2005
Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc·Product code CGN·July 22, 2019
IMx Folate Medium Control, list 2220-11; the pack contains 8 - 1 mL bottles of IMx Folate Medium Control M 7.0 ng/mL; Abbott Laboratories, Abbott Park, IL 60064 USA
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·December 16, 2003
ARCHITECT Folate Specimen Diluent, List 6C12Y, 5.5 mL (100 tests) and 25.9 mL (500 tests) bottles containing TRIS buffer with protein stabilizer, contained in ARCHITECT Folate Reagent Kit (Lists 6C12-20, 6C12-25, 6C12-30); Abbott Laboratories, Abbott Park, IL 60064 USA
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code CGN--·December 16, 2003
Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer.
FDA Recall
Terminated
·Beckman Coulter Inc·Product code CGN·November 8, 2004
ARCHITECT Folate Reagent, for in vitro diagnostics, List Numbers 07K60-20 (4 x 100 test kits), 07K60-25 (100 test kits)and 07K60-30 (4 x 500 test kits); manufactured by Abbott Ireland Diagnostic Division, Lisnamuck, Longford, Ireland.
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code CGN·March 28, 2007
Baxter RenAmin (Amino Acid) Injection; Pharmacy Bulk Package Not for Direct Infusion, Rx Only, 250 mL type II glass bottles; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, Made in USA; product code 2A6222.
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code CGN·February 15, 2010