Real Time Nucleic Acid Amplification System

The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).

Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.

Alinity m System, Part Number: 08N53-002

Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)

PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through

Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individu

Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.

Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.

Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use

Revogene, Catalog no. 610210. IVD test instrument

Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840

Alinity m Integrated Reaction Units (IRU)

Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455

ARIES HSV 1&2 Assay, Catalog/REF# 50-10017

cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190

ARIES HSV 1&2 Assay, Part Number/REF 50-10017

QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.

Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017

ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073

ARIES System and ARIES M1 System

BD Viper LT software, version 3.00H

BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat.

cobas PCR Urine Kit 100 PKT IVD cobas PCR Female Swab Kit 100 PKT IVD cobas PCR media 100T IVD cobas PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche

cobas 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.

Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas CT/NG 4800 System, for in vitro diagnostics.

Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with the Cobas 4800 System, is a real-time PCR test intended for the identification o

Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that results in quantitative and qualitative detection of nucleic acid sequences; Abbott Molecular Inc., Des P

NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic Test

MagNA Pure LC 2.0 Instrument, catalog number 05197686001, Roche Diagnostics, Indianapolis, IN MagNA Pure LC 2.0 instrument is a robotic instrument for automated isolation of nucleic acids (DNA, tot