Z-0387-2018 Class II Terminated
FDA device recall Z-0387-2018 was initiated by Phadia US Inc on July 5, 2017 and is designated Class II. Reason for recall: The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results. The recall status is terminated (terminated October 4, 2018). Affected quantity: 70 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2018
- Initiation Date
- July 5, 2017
- Termination Date
- October 4, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 units
Product Description
Phadia 1000 Instrument, Article Number 12-3800-01.
Reason for Recall
The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.
Distribution Pattern
Nationwide
Code Information
All versions of the instrument