Phadia Ab: Medical Device Recall in 2019 - (Recall #: Z-2397-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 9, 2019

Date Posted: September 4, 2019

Recall Number: Z-2397-2019

Event ID: 83402

Reason for Recall:

code 7-102 Liquid Sensor Error

Status: Terminated

Product Quantity: 387 Instruments

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

Voluntary or Mandated:

Voluntary: Firm initiated