Z-1368-2019Class II

Cobas infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For...

Name: Z-1368-2019 Cobas infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For...
Creator: Roche Diagnostics Corporation
Published: 2019-02-04
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2019-02-04 / Terminated / root cause: software

FDA source

Roche Diagnostics Corporation began a recall of Cobas infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use on 2019-02-04. FDA classified it as Class II and gives the reason as "Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does...". 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-1368-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-04
Posted: 2019-05-17
Terminated: 2020-09-16
Recalling firm: Roche Diagnostics GmbH
Product: Cobas infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.
Root cause tag: software
FDA root cause: Software design
Action: Roche Diagnostics issued on 2/04/19 an "URGENT MEDICAL DEVICE CORRECTION"(UMDC) letter to its customers via UPS Ground (receipt required). The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: " When using the automated bottle change function, ensure Good Laboratory Practices (GLP) are being followed (i.e., all QC results for the current and standby bottles are in range and are not flagged prior to testing patient samples). " Complete the attached fax form (TP-00548) and fax this form to 1-866-608-3939 or email it to [email protected]. " When a new software version is available, a Roche representative will contact you to schedule the software update. " File this UMDC for future reference. Contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-526-2272 if you have questions
Quantity in commerce: 15 units
Distribution: US Distribution to states of: AL, AZ, CA, GA, IA, MO, NJ, NY, SC, TN and TX.
Product codes and lots: Software versions 2.0 thorough 2.5 Serial Numbers: 81191 81371 81385 81465 81469 81470 81481 81485 81527 81528 81618 81628 81652 81655 81662

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1368-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1368-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-17

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)