Date Initiated by Firm |
October 11, 2012 |
Date Posted |
December 23, 2012 |
Recall Status1 |
Terminated 3 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 NJ 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 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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