Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Summary
The FDA issued a Class II for Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861 by Siemens Healthcare Diagnostics, Inc. Reason: Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the inte.
Details
Source
Device Recall
External ID
Z-0195-2022
Action Date
2021-11-10
Status
Terminated
Category
device
Product Description
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
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.
Quantity Affected: 149 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.
Distribution
US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-22
Company
East Walpole, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 120 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Siemens Healthcare Diagnostics, Inc has 166 FDA actions in our database, including 142 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Healthcare Diagnostics, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics, Inc have FDA actions?
Siemens Healthcare Diagnostics, Inc has 166 FDA actions in our database, including 142 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0195-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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