Device Recall Amplilink

Device-associated diagnostic software

General Hospital and Personal Use Devices

Unclassified

No

Nationwide Distribution

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.

Catalog number 20757497122, working probe suspension /IC PS1-IC4; Catalog Number 20757535122, Working substrate SB3-SB

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide to hospitals and laboratories.

Amplilink Software versions 1.1, 1.3, 1.4, 2.41. || COBAS Amplicor CTA & NGA Tests

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.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide Distribution

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.