cobas Liat Analyzer
This recall has been terminated (originally issued May 9, 2016).
- Company
- Roche Molecular Systems, Inc.
- Recall Initiated
- May 9, 2016
- Terminated
- March 24, 2021
- Recall Number
- Z-2216-2016
- Quantity
- 2
- Firm Location
- Branchburg, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed in NC and WA.
Lot / Code Info
US-IVD: M1-E-00383 & M1-E-00434
Root 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.