Z-2216-2016 Class II Terminated
FDA device recall Z-2216-2016 was initiated by Roche Molecular Systems, Inc. on May 9, 2016 and is designated Class II. 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 err… The recall status is terminated (terminated March 24, 2021). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- July 27, 2016
- Initiation Date
- May 9, 2016
- Termination Date
- March 24, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
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.
Distribution Pattern
Distributed in NC and WA.
Code Information
US-IVD: M1-E-00383 & M1-E-00434