Recall Z-2216-2016
Roche Molecular Systems, Inc. · initiated May 9, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
cobas Liat Analyzer
Codes / lots: US-IVD: M1-E-00383 & M1-E-00434
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2216-2016
- Initiated
- May 9, 2016
- Terminated
- March 24, 2021
- Product code
- OCC – Respiratory Virus Panel Nucleic Acid Assay System
- Quantity
- 2
- Distribution
- Distributed in NC and WA.
- Recalling firm
- Roche Molecular Systems, Inc., S Branchburg, NJ