Data / Medical devices / United States / Abbott Molecular, Inc.

Abbott Molecular, Inc.: FDA-registered device maker in Des Plaines, IL, United States, 19 510(k) clearances and 14 PMA approvals

Name: Abbott Molecular, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Abbott Molecular, Inc. is registered with the FDA (registration 3005248192) in Des Plaines, IL, United States. It lists 46 device types. The FDA files 19 510(k) clearances and 14 PMA approvals under its listings, the newest dated March 24, 2025. 34 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Abbott Molecular, Inc.

FDA registration number: 3005248192
Address: 1300 East Touhy Avenue, Des Plaines, IL, United States, 60018
Owner or operator: ABBOTT LABORATORIES (1415939)
Roles: Manufacturer, Manufacturer for export, Specification developer
First device listed: June 30, 1998
Registered through: 2027
Brand names listed: 20X SSC, 500g, AM Systems SCC Touchscreen Monitor, AMP Check E GPR, AUTOVYSION, Abbott Bisulfite Modification Kit, Abbott Bulk Universal Collection Kit (List 09N92-010), Abbott MultiCollect Specimen Collection Kit 09K12, Abbott Proteinase K and more

Devices it lists

Device	Product code	Class	Role	Source
Applicator, Absorbent Tipped, Sterile	KXG	1	Specification developer	accessdata.fda.gov
Assay, Genotyping, Hepatitis C Virus	OBF	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus	MZP	2	Manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Cells, Animal And Human, Cultured	KIR	1	Manufacturer	accessdata.fda.gov
Chronic Lymphocytic Leukemia Fish Probe Kit	OVQ	2	Manufacturer	accessdata.fda.gov
Clinical Sample Concentrator	JJH	1	Manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Cytomegalovirus (Cmv) Dna Quantitative Assay	PAB	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Device, Specimen Collection	LIO	1	Manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders	PFG	2	Manufacturer	accessdata.fda.gov
Dna Probe, Nucleic Acid Amplification, Chlamydia	MKZ	1	Manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Dna-Probe Kit, Human Chromosome	OYU	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment	OXP	2	Manufacturer	accessdata.fda.gov
Dna-Reagents, Epstein-Barr Virus	LSF	1	Manufacturer for export	accessdata.fda.gov
Dna-Reagents, Neisseria	LSL	2	Manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Early Growth Response 1 (Egr) Fish Probe Kit	OWK	2	Manufacturer	accessdata.fda.gov
Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization	PDO	2	Manufacturer	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Manufacturer for export	accessdata.fda.gov
Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement	OWE	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)	PNK	2	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Hepatitis Viral B Dna Detection	MKT	2	Manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples	PGI	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test	QUM	2	Manufacturer	accessdata.fda.gov
Kit, Dna Detection, Human Papillomavirus	MAQ	3	Manufacturer, Manufacturer for export	accessdata.fda.gov
Marker, Colon	NBG	2	Manufacturer for export	accessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	QOF	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna	QMI	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna	QLX	2	Manufacturer	accessdata.fda.gov
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	QEP	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic Acid	QJR	N	Manufacturer	accessdata.fda.gov
Reagents, Monkeypox Virus Nucleic Acid.	QTP	N	Manufacturer	accessdata.fda.gov
Reagents, Specific, Analyte	MVU	1	Manufacturer, Specification developer	accessdata.fda.gov
Reagents, Zika Virus Nucleic Acid	POA	N	Manufacturer	accessdata.fda.gov
Real Time Nucleic Acid Amplification System	OOI	2	Manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay System	OCC	2	Manufacturer for export	accessdata.fda.gov
Somatic Gene Mutation Detection System	OWD	3	Manufacturer, Manufacturer for export	accessdata.fda.gov
Stainer, Tissue, Automated	KEY	1	Manufacturer	accessdata.fda.gov
Station, Pipetting And Diluting, For Clinical Use	JQW	1	Manufacturer for export, Specification developer	accessdata.fda.gov
System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home	QYA	2	Specification developer	accessdata.fda.gov
System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays	NTH	2	Manufacturer	accessdata.fda.gov
System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex	MWA	2	Manufacturer for export	accessdata.fda.gov
System, Test, Her-2/Neu, Nucleic Acid Or Serum	MVD	2	Manufacturer	accessdata.fda.gov
Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence	NSD	3	Manufacturer	accessdata.fda.gov
Test, Hiv Detection	MZF	2	Manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Trichomonas Vaginalis Nucleic Acid Amplification Test System	OUY	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Urine Transport Kit (Excludes Hiv Testing)	OHZ	1	Manufacturer, Manufacturer for export	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 24, 2025	K241921	Alinity m BKV	QMI	Substantially Equivalent	Abbott Molecular, Inc.	accessdata.fda.gov
February 14, 2025	K241573	Alinity m Resp-4-Plex	QOF	Substantially Equivalent	Abbott Molecular, Inc.	accessdata.fda.gov
January 30, 2025	K243410	simpli-COLLECT STI Test	QYA	Substantially Equivalent	Abbott Molecular	accessdata.fda.gov
May 3, 2024	K233349	Alinity m HSV 1 & 2 / VZV	PGI	Substantially Equivalent	Abbott Molecular, Inc.	accessdata.fda.gov
March 3, 2023	K222379	Alinity m STI Assay	QEP	Substantially Equivalent	Abbott Molecular, Inc.	accessdata.fda.gov
July 15, 2022	K212778	Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)	QLX	Substantially Equivalent	Abbott Molecular, Inc.	accessdata.fda.gov
April 29, 2022	K202977	Alinity m STI Assay	QEP	Substantially Equivalent	Abbott Molecular, Inc.	accessdata.fda.gov
May 9, 2014	K140354	ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG	LSL	Substantially Equivalent	Abbott Molecular, Inc.	accessdata.fda.gov
September 13, 2013	K131508	VYSIS D7S486/CEP 7 FISH PROBE KIT	PFG	Substantially Equivalent	Abbott Molecular, Inc.	accessdata.fda.gov
July 29, 2013	DEN130010	VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)	PDO	Unknown	Abbott Molecular, Inc.	accessdata.fda.gov
August 29, 2011	K091960	VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020	OWK	Substantially Equivalent	Abbott Molecular, Inc.	accessdata.fda.gov
August 9, 2011	K100015	VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34	OVQ	Substantially Equivalent	Abbott Molecular, Inc.	accessdata.fda.gov
May 28, 2010	K092705	ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501	OOI	Substantially Equivalent	Abbott Molecular, Inc.	accessdata.fda.gov
July 10, 2008	K080739	ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT	MKZ	Substantially Equivalent	Abbott Molecular, Inc.	accessdata.fda.gov
December 13, 2004	DEN040010	VYSIS AUTOVYSION SYSTEM	NTH	Unknown	Vysis	accessdata.fda.gov
April 13, 2001	K010288	ANEUVYSION MULITICOLOR DNA PROBE KIT	OYU	Substantially Equivalent	Vysis	accessdata.fda.gov
January 21, 1997	K954214	CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT	OXP	Substantially Equivalent	Vysis	accessdata.fda.gov
January 13, 1997	K962873	CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE	OVQ	Substantially Equivalent	Vysis	accessdata.fda.gov
November 29, 1996	K953591	CEP 8 SPECTRUMORANGE DNA PROBE KIT	OYU	Substantially Equivalent	Vysis	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
November 1, 2023	P230003	Alinity m HR HPV	MAQ	19	September 2, 2026	accessdata.fda.gov
May 5, 2022	P210022	Alinity m CMV	PAB	12	September 13, 2024	accessdata.fda.gov
August 29, 2020	P200013	Alinity m HBV	MKT	26	October 17, 2025	accessdata.fda.gov
March 23, 2020	P190025	Alinity m HCV	MZP	6	June 1, 2021	accessdata.fda.gov
July 20, 2018	P170041	Abbott RealTime IDH1	OWD	9	May 28, 2026	accessdata.fda.gov
August 1, 2017	P170005	Abbott RealTime IDH2	OWD	6	May 28, 2026	accessdata.fda.gov
May 18, 2017	P160044	ABBOTT REALTIME CMV	PAB	5	January 13, 2023	accessdata.fda.gov
April 11, 2016	P150041	VYSIS CLL FISH PROBE KIT	PNK	8	February 18, 2026	accessdata.fda.gov
June 20, 2013	P120012	ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)	OBF	18	March 5, 2021	accessdata.fda.gov
August 26, 2011	P110012	VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK	OWE	23	February 18, 2026	accessdata.fda.gov
May 17, 2011	P100017	ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV	MZP	23	March 5, 2021	accessdata.fda.gov
August 13, 2010	P080026	ABBOTT REALTIME HBV ASSAY	MKT	24	April 18, 2025	accessdata.fda.gov
January 24, 2005	P030052	UROVYSION BLADDER CANCER KIT		30	February 18, 2026	accessdata.fda.gov
December 11, 1998	P980024	PATHVYSION HER-2 DNA PROBE KIT	MVD	22	March 18, 2022	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 28, 2025	96790	Class II	Ongoing	Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation	There were reports of an increase in reactive negative controls and false positive results.	accessdata.fda.gov
March 20, 2025	96559	Class II	Ongoing	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).	The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.	accessdata.fda.gov
September 12, 2024	95442	Class II	Ongoing	Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091	Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.	accessdata.fda.gov
March 20, 2024	94251	Class II	Ongoing	Alinity m System, Part Number: 08N53-002	The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar." Abbott has identified an issue concerning the use of certain third-party Universal Transport Medium (UTM) tubes on the Alinity m Sy	accessdata.fda.gov
February 1, 2024	93902	Class III	Ongoing	In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020	Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.	accessdata.fda.gov
October 30, 2023	93230	Class II	Ongoing	Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System	Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.	accessdata.fda.gov
December 9, 2022	91286	Class II	Ongoing	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.	The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconfiguration of the calibration. 2. Inability of Maintenance and Diagnostics 2300 (Amp Detect Optical Cali	accessdata.fda.gov
November 22, 2022	91202	Class II	Ongoing	Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096	Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.	accessdata.fda.gov
November 11, 2022	91777	Class II	Ongoing	Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.	The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results.	accessdata.fda.gov
October 12, 2022	91001	Class II	Ongoing	Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use	Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. It was found that the software will cause the flapper door to stay in the closed position when the drawer is closed and locked if the	accessdata.fda.gov
August 19, 2022	90789	Class II	Ongoing	Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.	Reports received of an increase of message code 9186 (internal control failed) when using the kit.	accessdata.fda.gov
July 19, 2022	90651	Class II	Completed	The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.	Incorrect optical calibration	accessdata.fda.gov
March 4, 2022	89757	Class II	Ongoing	Alinity m HBV Application Specification File (US and CE)	There is a potential for misquantitation high results of negative samples.	accessdata.fda.gov
February 11, 2022	89603	Class II	Terminated	Alinity m Integrated Reaction Units (IRU)	There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.	accessdata.fda.gov
December 6, 2021	89169	Class II	Terminated	Alinity m System, Part No. 08N53-002	There is an issue with the installation of updated camera firmware on the system.	accessdata.fda.gov
December 6, 2021	89168	Class II	Terminated	Alinity m System, Part No. 08N53-002	There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.	accessdata.fda.gov
December 6, 2021	89167	Class II	Ongoing	Alinity m System, Part No. 08N53-002	There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.	accessdata.fda.gov
December 6, 2021	89166	Class II	Ongoing	Alinity m System, Part No. 08N53-002	There is a potential for abnormal (non-sigmoidal) amplification curves.	accessdata.fda.gov
September 2, 2021	88626	Class I	Terminated	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic	There is a potential for false positive results.	accessdata.fda.gov
August 4, 2021	88565	Class II	Terminated	Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, SpectrumAqua/CEP 12 SpectrumGreen Probes	Potential for Vysis CLL FISH Probe Kits not detecting 13q deletions in known positive patient samples.	accessdata.fda.gov
October 23, 2014	69542	Class II	Terminated	Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.	Some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This issue will cause Error Code 9000 (An unexpected error has occurred: Software error) to be generated when the Available Reagent Packs screen is selected.	accessdata.fda.gov
June 19, 2014	68617	Class II	Terminated	5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reacti	Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 56944001, 57026001, 57059001, and 57673001 (original vendor lot 2198077) may have an insufficient rim. An RV with an insufficient rim may not be held securely in the 1 mL Subsystem Carrier. This may cause the RV to be seated incorrectly in the carrier or drop through i	accessdata.fda.gov
November 23, 2013	69300	Class II	Terminated	The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.	The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet.	accessdata.fda.gov
March 28, 2013	64791	Class III	Terminated	The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chromosome enumeration pr	20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellite) SG Probe, 20u, (part 32-112004 lot 438814), instead of the expected CEP 8 probe.	accessdata.fda.gov
December 4, 2012	63746	Class II	Terminated	Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system f	An issue with the m2000sp Instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the Sample Extraction Assay Details screen, the changes are not saved.	accessdata.fda.gov
January 31, 2012	62329	Class II	Terminated	Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list numbe	In the Abbott Molecular Bar Code Scanner User's Guide, List Number 6L88-02/09, the section Modifying the Keyboard Format for Bar Code Scanner LN 6L89-01 contains incorrect bar codes that can prevent the correct configuration of the bar code scanner language format. The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical lab	accessdata.fda.gov
October 11, 2011	60117	Not yet classified	Terminated	Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14	Abbott Molecular has received reports in which the liquid waste sensor and components in the m2000sp lower instrument cabinet overheated and/or caught fire.	accessdata.fda.gov
September 8, 2011	59768	Not yet classified	Terminated	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 Plaines, IL 60018 USA	The Abbott m2000rt System software has software bug which can affect customers who manually enter a Test Order onto the m2000rt and sorts a column on the calibration or control grids of the Test Order screen by double clicking the column header. This causes a mismatch between specific concentration values and the designated calibrators and controls in the fi	accessdata.fda.gov
December 20, 2010	57431	Not yet classified	Terminated	Abbott RealTime CT/NG Assay, List 8L07, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitati	Internal testing identified the potential of under filled and over filled enzyme reagent vials which may result in obtaining less than the total number of tests per kit as described on the package insert.	accessdata.fda.gov
July 20, 2010	56284	Not yet classified	Terminated	VP 2000 Processor Heated Reagent Basins; automated slide stainer; Abbott Molecular Inc., Des Plaines, IL 60018; The basins are sold under the the following part numbers: a) list 02J11-013, part number 30-144152 (replacem	The VP2000 Processor Heated Reagent Basins crack along the bottom seam, have non-uniform coating of interior corners, may be warped, and some may have incorrect dimensions.	accessdata.fda.gov
January 22, 2010	54190	Not yet classified	Terminated	Paraffin Pretreatment Reagent Kit II; each kit contains the following: 5 x 50 mL Pretreatment Solution (sodium thiocyanate - NaSCN), 5 x 62.5 mL Protease Buffer II (0.2N HCl), 5 x 250 mg Protease I (Pepsin, lyophilized,	The Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their labeling.	accessdata.fda.gov
September 15, 2008	52055	Not yet classified	Terminated	VP 2000 Processor; an automated tissue stainer 100 volt - part 30-144100 or list 2J11-60; 117 volt - part 30-144101 or list 2J11-01, and part 30-102832 - processor only; 230 volt - part 30-144102 or list 2J11-04, and par	Thermal runaway conditions, in that the target temperature was exceeded and the temperature display could not track the actual temperature within the heated slide basins of the VP 2000 Slide Processor.	accessdata.fda.gov
December 22, 2006	37363	Not yet classified	Terminated	Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 05J83-001; The prob	The LSI D13S319 SO/13q34 SA/CEP 12 SG probe of the two mixture DNA-Probe was contaminated with LSI ATM SG/p53 SO probe. This contamination would result in 10 FISH signals in each normal cell rather than the expected 6 FISH signals in each normal cell.	accessdata.fda.gov
October 28, 2005	33825	Not yet classified	Terminated	Vysis LSI p16 (9p21)/CEP 9 (9p11-q11) Dual Color Probe Set; a locus specific identifier DNA probe consisting of a mixture of the LSI p16 probe labeled with a SpectrumOrange and the CEP 9 probe labeled with a SpectrumGree	The DNA-Probe has a target size of ~300 Kb region instead of the labeled ~190 Kb region.	accessdata.fda.gov

Compare with other makers

Updated September 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.