What is FDA product code OOI?

The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system.

Clinical Chemistry › Laboratory InstrumentsReal Time Nucleic Acid Amplification System

M2000

Name: m2000
Brand: m2000

m2000sp SYSTEM SOFTWARE, Release 8.0

Registry build 21.09.26

15manufacturers in China registered for this device type

5catalogue numbers in this listing

1510(k) clearance

8recalls on this code

Who Else Makes It

Concentrated in Jiangsu (4), Shandong (3), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OOI
Manufacturer	City	Province	Registered as	Device types
Zhejiang Orient Gene Biotech	Huzhou	Zhejiang	Contract manufacturer	86
Guangzhou Four E’s Scientific Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	61
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Biobase Biodustry(Shandong)Co., Ltd.	Jinan	Shandong	Manufacturer	70
Infitek Co., Ltd.	Shanghai	Shanghai	Manufacturer	49
Labpeak Co., Ltd.	Jinan	Shandong	Manufacturer	43
Scitek Global Co., Ltd.	Jinan	Shandong	Manufacturer	43
Bioteke Corporation (Wuxi) Co., Ltd.	Wuxi	Jiangsu	Manufacturer	21
Getein Biotech, Inc.	Nanjing	Jiangsu	Manufacturer	19
Xian Tianlong Science AND Technology Co., Ltd.	Xi’An	Shaanxi	Manufacturer	8
Hangzhou Bioer Technology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	6
Sansure Biotech Inc.	Changsha	Hunan	Manufacturer	4

Showing 12 of 15. All 15 manufacturers in China registered for Real Time Nucleic Acid Amplification System

Record

Regulatory record for m2000
Listed by	Abbott Molecular, Inc., United States
FDA product code	OOI
Device type	Real Time Nucleic Acid Amplification System
Device class	Class 2
Regulation	21 CFR 862.2570
Establishment	Specification developer, Manufacturer, Exporter
510(k)	K092705
Record published	2016-09-01
Record revised	2025-07-14 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, serial number
Storage	Storage environment humidity 30 to 80 % RH; Storage environment temperature 15 to 30 °C

Catalogue Numbers

Catalogue numbers for m2000
Catalogue number	Size	Status
9K15-01		In distribution
4J71-75		In distribution
08N88-001		In distribution
08N89-001		In distribution
4J71-70		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
GeneXpert Dx System	Cepheid	37
Alinity m	Abbott Molecular, Inc.	20
GeneXpert Infinity-80 System	Cepheid	13
Fluorescence Quantitative PCR Detection System	Anitoa Biotechnology(Hangzhou)Co., Ltd.	12
GeneXpert®	Cepheid	10
Certified Pre-Owned GeneXpert Dx System	Cepheid	10
Bioer GeneExplorer Thermal Cycler	Hangzhou Bioer Technology Co., Ltd.	7
GeneXpert Infinity-48s System	Cepheid	5
Panther Fusion®	Hologic, Inc.	4
Bioer LineGene 9600 Plus Fluorescent Quantitative Detection System	Hangzhou Bioer Technology Co., Ltd.	4
Bioer QuantGene 9600 Fluorescent Quantitative Detection System	Hangzhou Bioer Technology Co., Ltd.	3
Q-Vera Prima 96 qPCR Instrument	Sansure Biotech Inc.	3

Showing 12 of 188. All products under Real Time Nucleic Acid Amplification System

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K092705	2010-05-28

Recalls Naming This Product

6 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of m2000
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Abbott Molecular, Inc.	510(k) number	2014-10-23	Class II	Software design (manufacturing process)	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 Avai	9 CD ROMs (US); 1,273 CD ROMs (Foreign)	2016-03-08
Abbott Molecular, Inc.	510(k) number	2014-06-19	Class II	Employee error	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	1,688,000 reaction vessels	2016-02-23
Abbott Molecular, Inc.	510(k) number	2013-11-23	Class II	Nonconforming Material/Component	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.	176 devices	2017-12-04
Abbott Molecular, Inc.	510(k) number	2012-12-04	Class II	Software design	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.	215 units – U.S., 693 units – ROW	2016-03-08
Abbott Molecular, Inc.	510(k) number	2011-10-11	Not classified	Component design/selection	Abbott Molecular has received reports in which the liquid waste sensor and components in the m2000sp lower instrument cabinet overheated and/or caught fire.	432 units	2016-02-23
Abbott Molecular, Inc.	510(k) number	2011-09-08	Not classified	Software design	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 he	926 units	2016-03-08

Recalls

6 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2025-03-20	Class II	Device Design	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 use
2024-03-20	Class II	Under Investigation by firm	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	1,012 units
2024-02-01	Class III	Process control	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.
2022-12-09	Class II	Under Investigation by firm	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	918 units
2022-11-11	Class II	Under Investigation by firm	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 poten	1
2022-10-12	Class II	Under Investigation by firm	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 foun	883 units
2022-02-11	Class II	Under Investigation by firm	There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.	3063 kits	2023-04-14

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.