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Terminated

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

FDA Recall Z-0195-2022 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc
Recall StatusTerminated
Product CodeQKP
Date Initiated2021-09-22
Date Terminated2022-08-02
Product Quantity149 kits

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.

Firm 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.

Root Cause

Device Design

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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