6 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Completed
×
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
FDA Enforcement
Class II
·Completed·Greiner Bio-One North America, Inc.·May 24, 2023
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
FDA Recall
Completed
·Greiner Bio-One North America, Inc.·Product code JKA·March 31, 2023
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.
FDA Recall
Completed
·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·Product code LCP·September 18, 2024
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
FDA Recall
Completed
·Beckman Coulter, Inc.·Product code JJE·January 3, 2024
Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
FDA Recall
Completed
·Abbott Laboratories, Inc·Product code JJE·September 29, 2017
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
FDA Recall
Completed
·Abbott Laboratories, Inc·Product code JJE·September 29, 2017