Z-0195-2022Class II

Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861

Name: Z-0195-2022 Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2021-09-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-09-22 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc began a recall of Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861 on 2021-09-22. FDA classified it as Class II and gives the reason as "Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0195-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-22
Posted: 2021-11-03
Terminated: 2022-08-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Product code: QKP Coronavirus Antigen Detection Test System.
Reason for recall: Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
Root cause tag: design
FDA root cause: Device Design
Action: On 9/22/2021, Siemens Healthineers issued Urgent Medical Device Correction notices to all US affected customers by FedEx beginning. The customer distribution included all US customers that have received the Atellica IM and ADVIA Centaur CoV2Ag assays. Actions to be Taken by the Customer - Discontinue use of and discard the kit lots listed in the notice. - Please discuss this letter with your Medical Director. - Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. - To receive credit for discarded product, please complete and return the form provided. If you have received any complaints of illness or adverse events associated with the products listed in the notice, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product.
Quantity in commerce: 149 kits
Distribution: US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI.
Product codes and lots: Lot # 44989001 - Exp. Date 2021-10-07, UDI # (01)00630414611846(10)44989001(17)20211007; Lot # 60407003 - Exp. Date 2021-03-22, UDI # (01)00630414611846(10)60407003(17)20211112.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0195-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0195-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-10	2021-11-03
Z-0196-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-10	2021-11-03

Product code QKP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)