Z-1233-2016Class II

cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and...

Name: Z-1233-2016 cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and...
Creator: Roche Diagnostics Operations, Inc.
Published: 2016-02-23
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2016-02-23 / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis on 2016-02-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1233-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-23
Posted: 2016-03-23
Terminated: 2018-01-11
Recalling firm: Roche Diagnostics GmbH
Product: cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 35 Units
Distribution: US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA
Product codes and lots: Part numbers:05083435001 and 06268854001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1233-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1233-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-23

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)