Reported Sep 29, 2021 · Terminated

Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st…

Beckman Coulter Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232

Access SARS CoV-2 IgG (1st IS) AssayAccess 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 codes and dates: 9 of 9 products
Products covered by this recall
Model / number Barcodes Product as published
C74339 15099590746919 UDI Code: (01)15099590746919(17)210930(11)210402(10)124466 Lot Number: 124466
C74340 15099590746926 UDI Codes: (01)15099590746926(17)210930(11)210402(10)124467
— 15099590746926 (01)15099590746926(17)211231(11)210703(10)124758
— Lot Numbers: 124467
— 124758
C74341 15099590746933 UDI Codes: (01)15099590746933(17)210930(11)210402(10)124468
— 15099590746933 (01)15099590746933(17)211130(11)210602(10)124708
— Lot Numbers: 124468
— 124708
Amount recalled: 303 kits (U.S.) and 964 kits (O.U.S.)

Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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128 in total.