Jan

2013

Cl ll COBAS AmpliPrep Instrument

Company: Roche Molecular Systems, Inc.
Date of Enforcement Report 1/2/2013
Class ll:

PRODUCT

COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland. Recall Number Z-0614-2013

REASON
Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that may not be flagged as having clots.

RECALLING FIRM/MANUFACTURER
Roche Molecular Systems, Inc, Branchburg, NJ 10/11/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
7 units

DISTRIBUTION
Distributed in the states of GA, CA, NC, and MN.

___________________________________

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 COBAS AmpliPrep Instrument

Amy Sellers

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