Who else makes this device?

Name: Advia Centaur® VitD DIL
Brand: Advia Centaur® VitD DIL

Advia Centaur® VitD DIL · System, Test, Vitamin D → Clinical Chemistry

1manufacturer

1catalogue number

4510(k) clearances naming this product code

8recalls on this code

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code MRG
Manufacturer	City	Province	Registered as	Device types
Shenzhen NEW Industries Biomedical Engineering Co., Ltd.	Shenzhen	Guangdong	Manufacturer	4

Record

Regulatory record for Advia Centaur® VitD DIL
Listed by	Siemens Healthcare Diagnostics Inc, United States
FDA product code	MRG
Device type	System, Test, Vitamin D
Device class	Class 2
Regulation	21 CFR 862.1825
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K110586
Record published	2016-09-24
Record revised	2023-06-02 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date
Storage	Special storage condition: store upright; Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Advia Centaur® VitD DIL
Catalogue number	Size	Per pack	Status
10494100		2	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
BioPlex 2200	Bio-Rad Laboratories Inc.	6
Access 25(OH) Vitamin D Total	Beckman Coulter, Inc.	3
Maglumi 25-OH Vitamin D	Shenzhen NEW Industries Biomedical Engineering Co., Ltd.	3
Architect	Abbott Medical	3
Atellica™ IM VitD	Siemens Healthcare Diagnostics Inc	2
1,25 Dihydroxy Vitamin D RIA	Immunodiagnostic Systems Ltd.	2
Maglumi 2000 25-OH Vitamin D	Shenzhen NEW Industries Biomedical Engineering Co., Ltd.	2
Alinity	Abbott Ireland	2
Architect	Abbott Ireland	2
Elecsys Vitamin D total II	Roche Diagnostics Gmbh	2
IDS-iSYS 25 VitDS	Immunodiagnostic Systems Ltd.	2
Elecsys Vitamin D total III	Roche Diagnostics Gmbh	2

Showing 12 of 50. All products under System, Test, Vitamin D

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K200509	2020-05-29
K162298	2017-03-16
K133156	2014-07-24
K110586	2011-10-14

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 Advia Centaur® VitD DIL
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Siemens Healthcare Diagnostics Inc	510(k) number	2016-10-05	Class II	Device Design	Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples	69781 kits	2019-08-29
Siemens Healthcare Diagnostics Inc	510(k) number	2016-10-05	Class II	Device Design	Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples	37437 kits	2019-08-29
Siemens Healthcare Diagnostics Inc	510(k) number	2014-04-10	Class II	Device Design	Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.	17,731 kits	2016-05-27
Siemens Healthcare Diagnostics Inc	510(k) number	2014-04-10	Class II	Device Design	Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.	12,787 kits	2016-05-27
Siemens Healthcare Diagnostics Inc	510(k) number	2014-04-10	Class II	Device Design	Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.	40,266 kits	2016-05-27
Siemens Healthcare Diagnostics Inc	510(k) number	2012-02-16	Not classified	Nonconforming Material/Component	Automatic and system-performed dilution calculation factor for Vitamin D dilutions is incorrect and causes diluted patient samples to under recover by approximately 50%.	442 units	2013-10-17

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. 2 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. 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
2013-03-13	Class II	No Marketing Application	Negative bias in patient samples for Vitamin D	4133	2015-03-05
2013-03-13	Class II	No Marketing Application	Negative bias in patient samples for Vitamin D	3871	2015-03-05

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.

Advia Centaur® VitD DIL