Who else makes this device?

Name: Vitros
Brand: Vitros

Vitros · Electrode, Ion Specific, Sodium → Clinical Chemistry

2manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

4recalls on this code

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code JGS
Manufacturer	City	Province	Registered as	Device types
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56

Record

Regulatory record for Vitros
Listed by	Ortho-Clinical Diagnostics, Inc., United States
FDA product code	JGS
Device type	Electrode, Ion Specific, Sodium
Device class	Class 2
Regulation	21 CFR 862.1665
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published	2016-08-26
Record revised	2023-06-21 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Vitros
Catalogue number	Size	Status
8379034		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Stat Profile	Nova Biomedical Corporation	13
i-STAT	Abbott Point OF Care Inc.	9
AU	Beckman Coulter, Inc.	8
GEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2	Instrumentation Laboratory SPA	8
Nova	Nova Biomedical Corporation	6
Phoenix Diagnostics, Inc.	Phoenix Diagnostics, Inc.	5
Sodium Electrode	Roche Diagnostics Gmbh	4
Pointe Scientific, Inc.	Horiba Instruments Incorporated	3
Architect	Abbott Laboratories	3
Synermed®	Infrared Laboratory Systems LLC	3
Sodium Electrode	Diamond Diagnostics Inc.	3
Phoenix Diagnostics	Phoenix Diagnostics, Inc.	2

Showing 12 of 88. All products under Electrode, Ion Specific, Sodium

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K091861	2009-09-03
K081411	2008-06-30

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Vitros
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Closed
Ortho-Clinical Diagnostics, Inc.	UDI-DI	2018-05-05	Class II	Nonconforming Material/Component	Potential for positively biased results	2021-02-19

Recalls

3 of these are Class II. Class II means a temporary or reversible health consequence. 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
2019-01-22	Class II	Under Investigation by firm	Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.	1448	2022-06-10
2016-12-20	Class II	Under Investigation by firm	There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at room temperature and loaded onto the analyzer after using the minimum warm up requirements st	659,957 Total Units (249,570 units domestically & 410,387 un	2018-06-22
2013-10-17	Class II	Under Investigation by firm	Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.	548,663 units	2018-05-18

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.

Vitros