Sep

2012

Cl ll Amplilink (AL) Software 3.2.3

Company:Roche Molecular Systems, Inc.
Date of Enforcement Report 9/26/12
Class ll:

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. Recall Number Z-2403-2012

REASON
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.

RECALLING FIRM/MANUFACTURER
Roche Molecular Systems, Inc., Branchburg, NJ on 4/23/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1292 instruments

DISTRIBUTION
Nationwide

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl ll Amplilink (AL) Software 3.2.3

Amy Sellers

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