Roche Amplilink Software Recall Due to Potential Wrong Test Results
Roche Molecular Systems is recalling Amplilink Software 3.2.3 because it may assign wrong results to orders when used with certain Laboratory Information Systems.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of harm (wrong test results) where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Roche Molecular Systems, Inc. is recalling Amplilink (AL) Software 3.2.3, which is used with COBAS AMPLICOR, CAP/CA, COBAS TaqMan, and COBAS AmpliPrep/COBAS TaqMan instruments. The recall affects 1,292 instruments distributed nationwide in the United States.
The recall was initiated because there is a potential for wrong results to be assigned to an order when the software is used with a Laboratory Information System (LIS) and automated systems utilizing the AMPLILINK software v3.2 series. This issue could lead to incorrect diagnostic information being associated with patient orders.
Healthcare facilities and laboratories using this software should contact Roche Molecular Systems for further instructions on how to address the potential for misassigned results. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- 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.
- Manufacturer
- Roche Molecular Systems, Inc.
- Affected units
- 1,292
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 05666678001
Distribution
Distributed nationwide across the United States.
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