Phadia US Inc: Medical Device Recall in 2018 - (Recall #: Z-0387-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Phadia 1000 Instrument, Article Number 12-3800-01.

Product Classification:

Class II

Date Initiated: July 5, 2017

Date Posted: January 24, 2018

Recall Number: Z-0387-2018

Event ID: 78752

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.

Status: Terminated

Product Quantity: 70 units

Code Information:

All versions of the instrument

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated