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