Skip to content
Recall Observatory FDA recall evidence

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

July 09, 2019

Class II

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

    reason.no_named_rule · v1.0.0

    code 7-102 Liquid Sensor Error