Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0204-2020)

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:

Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001

Product Classification:

Class II

Date Initiated: August 15, 2019

Date Posted: October 30, 2019

Recall Number: Z-0204-2020

Event ID: 83655

Reason for Recall:

Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

Status: Terminated

Product Quantity: 88 total US: 54;OUS 34

Code Information:

(SW) version V1.19.0 and V1.19.2 UDI: 00630414007960

Distribution Pattern:

Nationwide Foreign: Argentina Australia Bangladesh Belgium Brazil Colombia Dominican Republic Finland France Germany Greece Italy Japan Latvia Mexico Netherlands P.R. China Republic Korea Singapore Spain Switzerland Thailand United Kingdom Vietnam

Voluntary or Mandated:

Voluntary: Firm initiated