Z-0474-2021Class II

Atellica IM 1600 Analyzer -

Name: Z-0474-2021 Atellica IM 1600 Analyzer -
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2020-10-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-10-26 / Terminated / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens... on 2020-10-26. FDA classified it as Class II and gives the reason as "Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0474-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-26
Posted: 2020-11-19
Terminated: 2024-04-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066000
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Reason for recall: Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Siemens issued an Urgent Medical Device Correction (UMDC ASW21-01.A.US) via Fed'X to US Customers on 10/26/20 and Urgent Field Safety Notice, (UFSN ASW21-01.A.OUS) via electronic distribution to regional countries for implementation Outside US (OUS) The UMDC and UFSN explain the behaviors that can occur and instructs customers on actions to be taken for the issues described in the communication. Customers are requested to return the attached effectiveness check form via fax or email. A software version correcting the issues will be released when available and all systems will be updated.
Quantity in commerce: US: 214 units; OUS: 1082 units
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Peru, Poland, Portugal, Qatar Republic, Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay, Vatikancity, Vietnam.
Product codes and lots: Software version: V1.23.1 or lower UDI: 00630414002026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0474-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0473-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-25	2020-11-19
Z-0474-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-25	2020-11-19

Product code JLW

K151792Class IITrinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) SystemSiemens Healthcare Diagnostics, Inc. / cleared 2015-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)