Who else makes this device?

Name: Atellica CH Tacr
Brand: Atellica CH Tacr

Atellica CH Tacr · Enzyme Immunoassay, Tracrolimus → Clinical Chemistry

1manufacturer

1catalogue number

1510(k) clearance

7recalls on this code

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code MLM
Manufacturer	City	Province	Registered as	Device types
Shanghai Yunze Biotechnology Co., Ltd.	Minhang Disctrict	Shanghai	Manufacturer	1

Record

Regulatory record for Atellica CH Tacr
Listed by	Siemens Healthcare Diagnostics Inc, United States
FDA product code	MLM
Device type	Enzyme Immunoassay, Tracrolimus
Device class	Class 2
Regulation	21 CFR 862.1678
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K060385
Record published	2018-10-08
Record revised	2021-11-18 (version 3)

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; Do not freeze; Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Atellica CH Tacr
Catalogue number	Size	Status
11097542		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Architect	Abbott Ireland Diagnostics	2
Elecsys Tacrolimus	Roche Diagnostics Gmbh	2
Alinity	Abbott Ireland Diagnostics	2
Dimension® Flex® reagent cartridge TAC	Siemens Healthcare Diagnostics Inc	1
Syva® Emit® 2000 Tacrolimus Assay	Siemens Healthcare Diagnostics Inc	1
MassTrak™	Waters Corporation	1
QMS Tacrolimus Immunoassay	Microgenics Corporation	1
Alinity-Architect	Abbott Laboratories	1
Dimension® Flex® reagent cartridge Tacr	Siemens Healthcare Diagnostics Inc	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K150168	2015-11-04

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Atellica CH Tacr
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Siemens Healthcare Diagnostics Inc	510(k) number	2017-06-29	Class II	Device Design	Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.	10,067	2020-04-23

Recalls

5 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
2026-05-07	Class II	Under Investigation by firm	A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.	2878 units
2023-01-30	Class II	Under Investigation by firm	Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 and GA3171. The health consequences of erroneous patient result	6035 units
2013-07-01	Class II	Process control	Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 107) lot 3BD029. Falsely low Tacrolimus results across the ass	5423	2014-08-26
2013-04-25	Class II	Component design/selection	Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results.	13,751	2014-11-12
2012-11-27	Class II	Process control	Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low recovery of the same magnitude. Internal method regression testing	2,976	2014-08-04
2010-06-15	Not classified	Other	Low patient sample recovery results in all affected lots, with possibility of inappropriate increase in tacrolimus dosage based on false low result.	4580 Cartons	2010-12-16

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P970007	2002-09-05	IMX TACROLIMUS II	Abbott Laboratories
P970025	1999-04-27	PRO-TRAC II TACROLIMUS ELISA KIT	Diasorin Inc.

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 Tacr