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U.S. Department of Health and Human Services

Class 2 Device Recall COBAS AmpliPrep Sample Input Barcode Clips

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 Class 2 Recall
COBAS AmpliPrep Sample Input Barcode Clips
see related information
Date Posted August 15, 2012
Recall Status1 Terminated on July 16, 2013
Recall Number Z-2209-2012
Recall Event ID 62586
Product Classification Analyzer, Chemistry, Micro, For Clinical Use - Product Code JJF
Product COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample.
Code Information Lot Numbers: 11049503, 11053503, 11054503, 11525503 and 11526503.
Recalling Firm/
Manufacturer
Roche Molecular Systems, Inc.
1080 Us Highway 202 S
Branchburg, New Jersey 08876-3733
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mr. Vincent Stagnitto
908-253-7569
Manufacturer Reason
for Recall
Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tube and 12x24 S-clip) can cause the sample input tubes to stick in the barcode clips. As a consequence, the CAP instrument will lift both the sample input tube together with the barcode clip from the sample rack, resulting in an aborted run. No erroneous results would be produced if the issue occurs, but samples in proce
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action On 1/17/2012 an "Analyzer Bulletin" notification was sent to Roche affiliates and on 2/1/2012 an "Analyzer Bulletin" notification was sent to all affected US Consignees. The notification described the product issue and provided recommended actions. Customers were referred to Roche Technical Support at 800-526-1247 for questions.
Quantity in Commerce 2,132 boxes
Distribution Nationwide Distribution (USA).
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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