Z-1300-2019Class II

Atellica IM 1600 Analyzer, Material Number 11066000

Name: Z-1300-2019 Atellica IM 1600 Analyzer, Material Number 11066000
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2019-03-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2019-03-07 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica IM 1600 Analyzer, Material Number 11066000 on 2019-03-07. FDA classified it as Class II and gives the reason as "There were multiple issues identified in the system software which required an update". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1300-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-07
Posted: 2019-05-09
Terminated: 2020-08-20
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica IM 1600 Analyzer, Material Number 11066000
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Reason for recall: There were multiple issues identified in the system software which required an update.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Correction notification letters dated 3/7/19 were sent to customers.
Quantity in commerce: 366
Distribution: The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA, WV, WY, and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, Pakistan, Poland, Portugal Republic of Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, UK, and Vietnam.
Product codes and lots: UDI: 00630414002026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1300-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1299-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-09
Z-1300-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-09
Z-1301-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-09

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)