Device product
Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.
Z-2397-2019
Product summary
- Firm
- Phadia Ab
- Event
- Event 83402
- Status
- Terminated
- Classification
- Class II
- Quantity
- 387 Instruments
- Official record key
device-enforcement:Z-2397-2019
Official wording
Reason: code 7-102 Liquid Sensor Error
Code information: All Serial Numbers; Unique Device Identifier (UDI): 07333066001005
Distribution pattern: US Nationwide Distribution in the states of CA CO FL GA HI IL IN KS KY MA MD MI MO NC NJ NV NY OH OK OR PA TN TX UT VA WA
Derived failure modes
-
Unknown
code 7-102 Liquid Sensor Error