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IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious Mononucleosis.

FDA Recall
Terminated ·Alere San Diego, Inc.·Product code KTN·February 26, 2013

nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT; radiation monitoring dosimeter used with the microSTAR readers

FDA Recall
Completed ·Product code IYE·July 12, 2023

nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO; d) 03061-SMO; radiation monitoring dosimeter used with the microSTAR readers

FDA Recall
Completed ·Product code IYE·July 12, 2023

nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO; d) 03051-SMO; radiation monitoring dosimeter used with the microSTAR readers

FDA Recall
Completed ·Product code IYE·July 12, 2023

nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OTO; d) 03055-SMO; radiation monitoring dosimeter used with the microSTAR readers

FDA Recall
Completed ·Product code IYE·July 12, 2023

nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO; radiation monitoring dosimeter used with the microSTAR readers

FDA Recall
Completed ·Product code IYE·July 12, 2023

nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO; radiation monitoring dosimeter used with the microSTAR readers

FDA Recall
Completed ·Product code IYE·July 12, 2023

nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO; d) 03060-SMO; radiation monitoring dosimeter used with the microSTAR readers

FDA Recall
Completed ·Product code IYE·July 12, 2023

nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO; d) 03062-SMO; radiation monitoring dosimeter used with the microSTAR readers

FDA Recall
Completed ·Product code IYE·July 12, 2023

nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b) 03056-1MO; c) 03056-3MO; d) 03056-KIT; radiation monitoring dosimeter used with the microSTAR readers

FDA Recall
Completed ·Product code IYE·July 12, 2023

nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3MO; d) 03053-OTO; e) 03053-SMO; radiation monitoring dosimeter used with the microSTAR readers

FDA Recall
Completed ·Product code IYE·July 12, 2023

The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.

FDA Recall
Terminated ·Leica Microsystems, Inc.·Product code IEO·August 5, 2015

Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

FDA Recall
Open, Classified ·LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany·Product code IEO·November 20, 2023

Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.

FDA Recall
Terminated ·Richard-Allan Scientific Company·Product code IDO·August 12, 2011

ASP 6025 Vacuum Tissue Processor; an automated modular tissue processor; Leica Biosystems Nussloch GmbH, Heidelberger Str. 17-19, D-69226 Nussloch, Germany; The intended use of this device is as an automated system used to process tissue specimens for examination through fixation, dehydration, and infiltration.

FDA Recall
Terminated ·Leica Microsystems, Inc.·Product code IEO·March 30, 2012

Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.

FDA Recall
Terminated ·Leica Microsystems, Inc.·Product code IEO·November 13, 2012

Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.

FDA Recall
Terminated ·Ace Surgical Supply Co., Inc.·Product code EMO·March 28, 2018

HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.

FDA Recall
Open, Classified ·Leica Biosystems Melbourne Pty Ltd·Product code IEO·April 2, 2025

ThermoFisher Scientific Microm STP 420D automated tissue processor.

FDA Recall
Terminated ·Thermo Fisher Scientific·Product code IEO·June 3, 2009

Peloris Rapid Tissue Processor; Leica Biosystems Melbourne Pty Ltd, Mount Waverly, 3149 VIC, Australia; catalog number 26.0001 and 26.0005

FDA Recall
Terminated ·Leica Microsystems, Inc.·Product code IEO·February 9, 2010