Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2405-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026

Product Classification:

Class II

Date Initiated: May 7, 2020

Date Posted: July 1, 2020

Recall Number: Z-2405-2020

Event ID: 85687

Reason for Recall:

Insufficient sample may not be detected when using Tube Top Sample Cup (TTSC) or V-shaped Sample Cup sample containers with the Atellica IM1300 and Atellica IM1600 analyzers.

Status: Ongoing

Product Quantity: 1329

Code Information:

Atellica Tube Top Sample Cups, 1 mL, SMN 11069061; Atellica Tube Top Sample Cups, 2 mL, SMN 11069062; Sarstedt 62.612, 15.3 x 92 False Bottom, 4 mL

Distribution Pattern:

Worldwide distribution including to the following states: Florida, New Jersey, New York, California, Arizona, Colorado, Pennsylvania, Virginia, Ohio, Texas, Alabama, Nebraska, Wisconsin, Montana, Kentucky, Washington DC, Massachusetts, North Carolina, Georgia, Louisiana, Kansas, South Carolina, Tennessee, Iowa, Rhode Island, South Dakota, New Hampshire, Maryland, Oregon, Indiana, Idaho, Connecticut, Puerto Rico, West Virginia, Washington, Illinois, Utah, Maine, Minnesota, Wyoming, Nevada, Michigan, Missouri, and New Mexico.

Voluntary or Mandated:

Voluntary: Firm initiated