FDA-Device2013-01-02Class II
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
Roche Molecular Systems, Inc.
Hazard
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.
Sold states
Distributed in the states of GA, CA, NC, and MN.
Affected count
7 units
Manufactured in
1080 Us Highway 202 S, N/A, Branchburg, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0614-2013Don't want to check this manually?
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