Recall Z-1158-2020
Roche Diagnostics Operations, Inc. · initiated January 7, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
Codes / lots: All cobas infinity laboratory solution software versions are affected.
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.
FDA-determined cause: Under Investigation by firm
Action taken
On 1/7/2020, the firm distributed Urgent Medical Device Correction letters to affected consignees. Customers were asked to do the following: " Be aware of the incorrect display of the alarm flags on the cobas infinity Validation screen if an alarm has a < symbol in front of it and if doing manual validations. " It is not recommended to use the alarm mapping function on the cobas infinity until your system is patched. If your laboratory does use it, please call the Roche Support Network Customer Support Center at 1-800-526-2272 for further information. " Complete the customer response form and return it to the recalling firm. 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 the information contained in this UMDC.
Details
- Recall number
- Z-1158-2020
- Initiated
- January 7, 2020
- Terminated
- October 15, 2020
- Product code
- JQP – Calculator/Data Processing Module, For Clinical Use
- Quantity
- 26 accounts
- Distribution
- Distributed to customers in AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, and TN.
- Recalling firm
- Roche Diagnostics Operations, Inc., Indianapolis, IN