Who else makes this device?

Name: Atellica CH Hdlc
Brand: Atellica CH Hdlc

Atellica CH Hdlc · Ldl & Vldl Precipitation, Cholesterol via Esterase-Oxidase, Hdl → Clinical Chemistry

2manufacturers in China registered for this device type

1catalogue number

1recall

Who Else Makes It

Concentrated in Guangdong (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LBS
Manufacturer	City	Province	Registered as	Device types
Dongguan BAO Kang Dian ZI KE JI Limited	Dongguan	Guangdong	Contract manufacturer	24
Shijiazhuang Hipro Biotechnology Co., Ltd.	Shijiazhuang	Hebei	Manufacturer	22

Record

Regulatory record for Atellica CH Hdlc
Listed by	Siemens Healthcare Diagnostics Inc, United States
FDA product code	LBS
Device type	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Device class	Class 1
Regulation	21 CFR 862.1475
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2022-07-08
Record revised	2023-07-06 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C; Special storage condition: Protect from light, do not freeze; Handling environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Atellica CH Hdlc
Catalogue number	Size	Per pack	Status
11537213		4	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
JAS Diagnostics	Drew Scientific, Ltd.	6
Direct HDL-Cholesterol (HDL)	Randox Laboratories Limited	4
Synermed®	Infrared Laboratory Systems LLC	4
AU	Beckman Coulter, Inc.	4
HDL-Cholesterol Gen.4	Roche Diagnostics Gmbh	4
Direct HDL Cholesterol LiquiColor®	Stanbio Laboratory, L.P.	3
Ultra N-geneous HDL Cholesterol Reagent	Sekisui Diagnostics, LLC	2
Advia® Chemistry D-HDL Direct HDL Cholesterol Reagents	Siemens Healthcare Diagnostics Inc	2
Vitros	Ortho-Clinical Diagnostics, Inc.	2
Alinity	Abbott Medical	2
ox-LDL Elisa	Immundiagnostik, Inc.	2
ACE	Alfa Wassermann	2

Showing 12 of 30. All products under Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Recalls Naming This Product

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

Recalls naming the identifiers of Atellica CH Hdlc
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Siemens Healthcare Diagnostics Inc	UDI-DI	2023-07-10	Class II	Under Investigation by firm	Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica CH Total Bilirubin_2 (TBil_2), Atellica CH LDL Choleste	18524 units

Recalls

1 of these is 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
2016-03-17	Class II	Device Design	Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn	137422 units total	2017-09-25

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.

Atellica CH Hdlc