Devices

Device Recall Amplilink

Model / Serial
Catalog number 03576710190, working substrate SB3-SB
Product Classification
Immunology and Microbiology Devices
Device Class
3
Implanted device?
No
Distribution
Nationwide to hospitals and laboratories.
Product Description
Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 || COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0
Manufacturer
Roche Molecular Systems, Inc.
1 Event
- Recall of Device Recall Amplilink

Manufacturer

Roche Molecular Systems, Inc.

Manufacturer Address
Roche Molecular Systems, Inc., 1080 US Highway 202 S, Somerville NJ 08876-3733
Source
USFDA

3 devices with a similar name

Learn more about the data here

Device Recall AMPLILINK

Model / Serial
Device-associated diagnostic software
Product Classification
General Hospital and Personal Use Devices
Device Class
Unclassified
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.
Manufacturer
Roche Molecular Systems, Inc.

Device Recall Amplilink

Model / Serial
Catalog number 20757497122, working probe suspension /IC PS1-IC4; Catalog Number 20757535122, Working substrate SB3-SB
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide to hospitals and laboratories.
Product Description
Amplilink Software versions 1.1, 1.3, 1.4, 2.41. || COBAS Amplicor CTA & NGA Tests
Manufacturer
Roche Molecular Systems, Inc.

Device Recall AMPLILINK Software, version 3.1.0 to 3.2.2

Model / Serial
Version 3.1.0, Version 3.1.1, Version 3.1.2, Version 3.2.0, Version 3.2.1, and Version 3.2.2.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 05093236001, and catalog number 05201357001. || Automated sample preparation for nucleic acid analysis on either the COBAS TaqMan or COBAS TaqMan 48. COBAS AmpliPrep/COBAS TaqMan is capable of tunning HBV, HCV, and HIV tests.
Manufacturer
Roche Molecular Systems, Inc.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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