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Recall Observatory FDA recall evidence

Device product

cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.

Z-1158-2020

January 07, 2020

Class II

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 84697
Status
Terminated
Classification
Class II
Quantity
26 accounts
Official record key
device-enforcement:Z-1158-2020

Official wording

Reason: 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.

Code information: All cobas infinity laboratory solution software versions are affected.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.