—#143776

Product

cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Part numbers:05083435001 and 06268854001

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

Roche 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.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA

Timeline

Recall initiated: 2016-02-23
Terminated: 2018-01-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143776. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.