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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica IM SARSCoV2 Antigen (CoV2Ag) Assay

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  Class 2 Device Recall Atellica IM SARSCoV2 Antigen (CoV2Ag) Assay see related information
Date Initiated by Firm September 22, 2021
Create Date November 03, 2021
Recall Status1 Terminated 3 on August 02, 2022
Recall Number Z-0195-2022
Recall Event ID 88768
Product Classification Coronavirus antigen detection test system. - Product Code QKP
Product Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Code Information 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.
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact
508-668-5000
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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