—#189491

Product

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

FDA product code: QKP — Coronavirus Antigen Detection Test System.
Device class: Class N
Medical specialty: Unknown
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI.

Timeline

Recall initiated: 2021-09-22
Terminated: 2022-08-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #189491. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.