Roche Diagnostics Corporation: Medical Device Recall in 2019 - (Recall #: Z-1368-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 4, 2019

Date Posted: May 29, 2019

Recall Number: Z-1368-2019

Event ID: 82139

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.

Status: Terminated

Product Quantity: 15 units

Code Information:

Software versions 2.0 thorough 2.5 Serial Numbers: 81191 81371 81385 81465 81469 81470 81481 81485 81527 81528 81618 81628 81652 81655 81662

Distribution Pattern:

US Distribution to states of: AL, AZ, CA, GA, IA, MO, NJ, NY, SC, TN and TX.

Voluntary or Mandated:

Voluntary: Firm initiated