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U.S. Department of Health and Human Services

Class 2 Device Recall Roche COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL)

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 Class 2 Recall
Roche COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL)
see related information
Date Posted December 23, 2012
Recall Status1 Terminated on September 11, 2013
Recall Number Z-0614-2013
Recall Event ID 63814
Product Classification Clinical Sample Concentrator - Product Code JJH
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
Code Information CAP 394436 to 394663
Recalling Firm/
Manufacturer
Roche Molecular Systems, Inc.
1080 Us Highway 202 S
Branchburg, New Jersey 08876-3733
For Additional Information Contact Mr. Vincent Stagnitto
908-253-7569
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Device Design
Action Roche sent an Urgent Medical Device Correction notification/Fax Back forms dated 10/11/12 to potentially affected customers. The letter identified the affected product, the issue, clinical significance, workaround, and required actions, along with contact information. Customers are to use the workaround until their Roche FSE has performed a Master Initialization on their affected instruments. Also, the letter should be filed for future reference. Questions should be directed to Roche Molecular Diagnostics Technical Support at 1-800-526-1247.
Quantity in Commerce 7 units
Distribution Distributed in the states of GA, CA, NC, and MN.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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