Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1
Summary
The FDA issued a Class II for Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK by Beckman Coulter Inc.. Reason: Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute.
Details
Source
Device Recall
External ID
Z-2508-2021
Action Date
2021-09-29
Status
Terminated
Category
device
Product Description
Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341
Lot/Code Info: Part Number: C74339 UDI Code: (01)15099590746919(17)210930(11)210402(10)124466 Lot Number: 124466; Part Number: C74340 UDI Codes: (01)15099590746926(17)210930(11)210402(10)124467; (01)15099590746926(17)211231(11)210703(10)124758; Lot Numbers: 124467; 124758; Part Number: C74341 UDI Codes: (01)15099590746933(17)210930(11)210402(10)124468; (01)15099590746933(17)211130(11)210602(10)124708; Lot Numbers: 124468; 124708;
Quantity Affected: 303 kits (U.S.) and 964 kits (O.U.S.)
Reason for Recall
Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute
Distribution
U.S. Nationwide distribution in the states of AZ, CA, GA, IL, IA, KY, MI, NJ, NY, NC, OH, PA, Puerto Rico, TN, TX, VA, and WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-05
Company
Brea, CA
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 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter Inc. has 158 FDA actions in our database, including 111 recalls and 47 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 (Beckman Coulter Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter Inc. have FDA actions?
Beckman Coulter Inc. has 158 FDA actions in our database, including 111 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2508-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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