Z-1158-2020 Class II Terminated
FDA device recall Z-1158-2020 was initiated by Roche Diagnostics Operations, Inc. on January 7, 2020 and is designated Class II. Reason for recall: Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity … The recall status is terminated (terminated October 15, 2020). Affected quantity: 26 accounts.
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2020
- Initiation Date
- January 7, 2020
- Termination Date
- October 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 accounts
Product Description
cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
Reason for Recall
Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.
Distribution Pattern
Distributed to customers in AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, and TN.
Code Information
All cobas infinity laboratory solution software versions are affected.