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cobas infinity central lab, Material Number 07154003001 recallZ-0952-2023 · Roche Diagnostics Operations, Inc. · initiated Dec 12, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Roche Diagnostics Operations, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information System (LIS) is created with an Internal ID rather than the External ID sent from the LIS. The erroneous event occurs under rare circumstances where the date in the sample's barcode does not match the order date sent from the LIS, and can lead to the order being mismatched to an another patient's sample ID rather than the subject patient's sample ID. The software bug impacts multiple cobas infinity central lab software (versions 2.5.x , 3.01.x, 3.02.x, and 3.03.x) and occurs when the afflicted software has been configured with specific pre-conditions.

FDA root cause category: Software design

What the company is doing

On December 12, 2022, the firm notified affected customers through Urgent Medical Device Correction letters. Customers were informed of the product issue. A Roche Diagnostics representative will contact you in the near future to assess your cobas infinity configuration and to determine if it meets all pre-conditions. If so, your Roche representative will work with you to implement a workaround immediately in addition to working with you to apply a more permanent solution via a software patch once available. Customers should consult with a physician or pathologist at your facility to determine clinical implications specific to your patients. Please 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 about this recall.

Recall details

Recall number
Z-0952-2023
Status
Open, Classified
Initiated by the company
Dec 12, 2022
Posted by the FDA
Jan 12, 2023
Recalling firm
Roche Diagnostics Operations, Inc.
Quantity
224 US; 2,797 worldwide
Product code
JQP
Distribution
Domestic distribution nationwide. Foreign distribution pending.

Product description

cobas infinity central lab, Material Number 07154003001

Code information (models, lots, serial numbers)

cobas infinity central lab / cobas infinity core license using software versions (2.5.x , 3.01.x, 3.02.x, and 3.03.x) that have been configured with all of the following pre-conditions will be impacted: 1. Having Order ID configuration to include the date (Not Common in U.S. Configurations) 2. Having a host configured by Order rather than Tube (Not Common in U.S..Configurations) 3. Having message configured to receive registration date of the order using ExtRegisterDate and ExtRegisterHour. 4. Having HCA configuration enabled for " Reject orders if not possible to assign External ID" and the radio button option set to "To at least one test" UDI-DI 04015630936007

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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