Who else makes this device?

Name: cobas z 480
Brand: cobas z 480

Immunology & Microbiology › Serological ReagentsDna Probe, Nucleic Acid Amplification, Chlamydia

Cobas Z 480

Catalogue number 05200881001, listed by Roche Molecular Systems, Inc., United States, under Dna Probe, Nucleic Acid Amplification, Chlamydia. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

5510(k) clearances naming this product code

1recall

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MKZ
Manufacturer	City	Province	Registered as	Device types
Hochuen Medical Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	20

Record

Regulatory record for cobas z 480
Listed by	Roche Molecular Systems, Inc., United States
FDA product code	MKZ
Device type	Dna Probe, Nucleic Acid Amplification, Chlamydia
Device class	Class 1
Regulation	21 CFR 866.3120
Establishment	Specification developer, Manufacturer, Exporter
Record published	2014-09-15
Record revised	2025-07-14 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number
Distribution end date	2018-07-02

Catalogue Numbers

Catalogue numbers for cobas z 480
Catalogue number	Size	Status
05200881001		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Aptima®	Hologic, Inc.	7
Aptima Combo 2®	Hologic, Inc.	4
Alinity m	Abbott Molecular, Inc.	2
Multi-Collect	Abbott Molecular, Inc.	1
BD ProbeTec™ Chlamydia trachomatis Qx Assay Gray Amp Reagent Pack	Becton, Dickinson AND Company	1
BD Molecular Swab Sample Buffer Tubes	Becton, Dickinson AND Company	1
cobas&#x00AE PCR Media Uni Swab Sample Kit	Roche Molecular Systems, Inc.	1
BD Molecular LBC Sample Buffer Tubes	Becton, Dickinson AND Company	1
cobas Ctng Qualitative nucleic acid test for use on the cobas 6800/8800 Systems	Roche Molecular Systems, Inc.	1
Progensa	Hologic, Inc.	1
BD CTGCTV2	Becton, Dickinson AND Company	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K110923	2012-01-24
K973707	1999-08-04
K973718	1998-12-15
K964507	1997-06-13
K922906	1993-06-15

Recalls Naming This Product

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

Recalls naming the identifiers of cobas z 480
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Roche Molecular Systems, Inc.	UDI-DI	2020-11-19	Class II	Device Design	Dirty Lens May Cause Invalid or False Positive Results	597 units US; 3411 units OUS	2023-08-10

Recalls

The FDA has not published a severity grade for these. 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
2004-07-07	Not classified	Other	An increased frequency of ‘blue foci’ that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.	2400 kits	2005-01-07

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.