Roche Molecular Systems, Inc. Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests
Brand
Roche Molecular Systems, Inc.
Lot Codes / Batch Numbers
Catalog number 20757497122, working probe suspension /IC PS1-IC4, Catalog Number 20757535122, Working substrate SB3-SB
Products Sold
Catalog number 20757497122, working probe suspension /IC PS1-IC4; Catalog Number 20757535122, Working substrate SB3-SB
Roche Molecular Systems, Inc. is recalling Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests due to For select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a discrepancy has been identified between t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026