Recall Z-2216-2016— Roche Molecular Systems, Inc.

Name: FDA recall Z-2216-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-09

Class II · Terminated

Class II FDA medical device recall by Roche Molecular Systems, Inc., initiated 2016-05-09, terminated 2021-03-24. It names one FDA 510(k) clearance: K111387. Product: cobas¿ Liat¿ Analyzer. Reason: 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..

Recalling firm: Roche Molecular Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-05-09
Terminated: 2021-03-24
Firm location: Branchburg, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K111387 — LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZERIquum, Inc.·cleared 2011-08-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

cobas¿ Liat¿ Analyzer

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.