Skip to content
Recall Observatory FDA recall evidence

Device product

cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.

Z-2203-2016

May 17, 2016

Class III

Product summary

Firm
Roche Molecular Systems, Inc.
Event
Event 74154
Status
Terminated
Classification
Class III
Quantity
194 distributed kits
Official record key
device-enforcement:Z-2203-2016

Official wording

Reason: Kit labeled with the incorrect expiration date.

Code information: Lot Numbers: 51222E, 60121H, 60201D, and 60229F

Distribution pattern: Distributed in the states of: TX, NY, OR, HI, MD, PA, NC, MA, IA, WA, OR, AK, ME, MN, VA, MT, PA, and LA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Kit labeled with the incorrect expiration date.