Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR Recalled by Roche Molecular Systems, Inc. Due to When using a Laboratory Information system (LIS) with...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Roche Molecular Systems, Inc. directly.
Affected Products
Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.
Quantity: 1292 instruments
Why Was This Recalled?
When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2 series (AL v3.2) there is a potential for wrong results to be assigned to an order.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc. has 42 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report