cobas infinity central lab, Material Number 07154003001

FDA device recall Z-0952-2023 · posted 2023-01-12 · Open, Classified

Recall details

Recalling firm

Roche Diagnostics Operations, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Software design

Status

Open, Classified

Product code

JQP

Quantity affected

224 US; 2,797 worldwide

Distribution

Domestic distribution nationwide. Foreign distribution pending.

Date initiated

2022-12-12

Date posted

2023-01-12

Location

Indianapolis, IN