Z-0125-2022Class II

Atellica IM 1600 Analyzer, SMN 11066000

Name: Z-0125-2022 Atellica IM 1600 Analyzer, SMN 11066000
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2021-09-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-09-28 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of Atellica IM 1600 Analyzer, SMN 11066000 on 2021-09-28. FDA classified it as Class II and gives the reason as "Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0125-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-28
Posted: 2021-10-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica IM 1600 Analyzer, SMN 11066000
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.
FDA root cause: Under Investigation by firm
Action: On September 27, 2021, the firm initiated notifications to affected customers. Customer distribution included all customers located in a city at an altitude of 350 meters (1148 feet) or higher. Customers were informed that Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350 (m) or 1148 (ft) above sea level. The letters provide directions for mitigating the potential for leakage. If you have any questions, contact your local Siemens Healthineers technical support representative.
Quantity in commerce: 1733
Distribution: Domestic distribution to AZ CA CO GA ID KS MO MT NC NE NM NV OH OK OR PA TN TX UT VA WA WI WY. Foreign distribution worldwide.
Product codes and lots: All units.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0125-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0124-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-27	2021-10-16
Z-0125-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-27	2021-10-16

Product code JJE

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)