23 results
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50ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.
FDA Recall
Terminated
·MEDLINE INDUSTRIES, LP Northfield·Product code LIQ·January 25, 2022
Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
FDA Recall
Terminated
·MEDLINE INDUSTRIES, LP Northfield·Product code DIF·November 30, 2021
Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
FDA Recall
Terminated
·MEDLINE INDUSTRIES, LP Northfield·Product code JIN·March 8, 2022
Michels Transport Medium, 20ML Prefilled Cont
FDA Recall
Terminated
·MEDLINE INDUSTRIES, LP Northfield·Product code NNI·December 1, 2021
Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.
FDA Recall
Terminated
·MEDLINE INDUSTRIES, LP Northfield·Product code NGT·March 4, 2022
Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.
FDA Recall
Terminated
·MEDLINE INDUSTRIES, LP Northfield·Product code DKB·March 8, 2022
CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
FDA Recall
Terminated
·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·September 7, 2022
VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
FDA Recall
Terminated
·MEDLINE INDUSTRIES, LP Northfield·Product code OFF·September 1, 2022
Premier Rotaclone, Rx only
FDA Recall
Terminated
·MEDLINE INDUSTRIES, LP Northfield·Product code LIQ·December 1, 2021
ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
FDA Recall
Terminated
·MEDLINE INDUSTRIES, LP Northfield·Product code CIC·October 22, 2021
HARDY DIAGNOSTICS CatScreen, 25dsk/vial
FDA Recall
Terminated
·MEDLINE INDUSTRIES, LP Northfield·Product code JTO·December 1, 2021
meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES, LP - Northfield·March 2, 2022
Michels Transport Medium, 20ML Prefilled Cont
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES, LP - Northfield·March 2, 2022
ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES, LP - Northfield·June 1, 2022
Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES, LP - Northfield·April 13, 2022
HARDY DIAGNOSTICS CatScreen, 25dsk/vial
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES, LP - Northfield·February 9, 2022
Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES, LP - Northfield·April 20, 2022
Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES, LP - Northfield·December 29, 2021
Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES, LP - Northfield·April 20, 2022
Premier Rotaclone, Rx only
FDA Enforcement
Class II
·Terminated·MEDLINE INDUSTRIES, LP - Northfield·February 9, 2022