Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests
Hazard
For select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a discrepancy has been identified between the onboard working reagent stability information reported by AMPLILINK Software (versions 1.1, 1.3, 1.4 and 2.41) and the stability information provided in the test kit package inserts/method manual.
What You Should Do
Remedy
Urgent Medical Device Correction letters were mailed on 5/21/07 by first class mail. Letters describe the discrepancy between software reagent expiration dates and package insert expiration dates.
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Products
Amplilink Software versions 1.1, 1.3, 1.4, 2.41.
COBAS Amplicor CTA & NGA Tests
- Brand
- Roche Molecular Systems, Inc.
- UPC
- Catalog number 20757497122, working probe suspension /IC PS1-IC4; Catalog Number 20757535122, Working substrate SB3-SB
Units Affected
5,806 total