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U.S. Department of Health and Human Services

Class 2 Device Recall cobas p 512 preanalytical system

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 Class 2 Device Recall cobas p 512 preanalytical systemsee related information
Date Initiated by FirmFebruary 23, 2016
Create DateMarch 23, 2016
Recall Status1 Terminated 3 on January 11, 2018
Recall NumberZ-1233-2016
Recall Event ID 73292
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Productcobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
Code Information Part numbers:05083435001 and 06268854001
Recalling Firm/
Manufacturer
Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactTodd Siesky
317-521-3911
Manufacturer Reason
for Recall
Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly placed back in the Rack Tube Transport (RTT) after the decapping process. Therefore, open sample tubes can be dropped in the cobas p 512, spilling the sample material.
FDA Determined
Cause 2
Software design
ActionRoche Diagnostics sent an "Urgent Medical Device Correction" letter via UPS Ground (receipt required) on February 23, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. To prevent this malfunction, a software patch has been developed and validated. The installation of this software patch is mandatory and will be performed by a Roche Field Engineering Specialist (FES). Your Roche FES will contact you to schedule the installation of the software patch. Until the software patch is implemented, Roche recommends that instrument operators monitor their systems for the occurrence of Error 140 Gripper has lost tube. If this error occurs, all components in contact with a spill must have extra cleaning. Refer to the cobas p 512 pre-analytical instrument Operators Manual Version 1.5. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 for further questions.
Quantity in Commerce35 Units
DistributionUS Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA
Total Product Life CycleTPLC Device Report

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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