Liat (Tm) Influenza a / B Assay, Liat (Tm) Analyzer

510(k) K111387

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

Recall on shared 510(k) K111387; other models may be affected

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK111387	Date4 Aug 2011Cleared	StatusActive

4 recalls · 1 ongoing · FDA

- Ongoing Z-0828-2022 FDA Class II initiated 16 Nov 2021 on shared 510(k) K111387
Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.
- Terminated Z-2203-2016 FDA Class III initiated 17 May 2016
Kit labeled with the incorrect expiration date.
- Terminated Z-2216-2016 FDA Class II initiated 9 May 2016
Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.
- Terminated Z-2543-2015 FDA Class II initiated 24 Jul 2015
Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the LED printed circuit board assemblies (PCBA) in certain cobas Liat Analyzers.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)