cobas Liat Analyzer
FDA Recall Z-2216-2016 · Posted None
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Recalling FirmRoche Molecular Systems, Inc.
Recall StatusTerminated
Product CodeOCC
Date Initiated2016-05-09
Date Terminated2021-03-24
Product Quantity2
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.
Firm Action
Customers were notified of the recall via phone and email sent on 5/9/2016. They were instructed to take the following actions: Immediately discontinue use of the affected instruments until they have been reworked by a Roche Field Engineering Specialist. A Roche representative will contact you to schedule this service. Complete the attached fax form and fax it to 1-317-521-4815. File this Urgent Medical Device Correction (UMDC) for future reference. Please contact the Roche Support Network Customer Support Center 1-800-800-5973 if you have questions.
Root Cause
Under Investigation by firm
Distribution Pattern
Distributed in NC and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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