Beckman Coulter Inc.: 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

Recall number

Z-2508-2021

Recalling firm

Beckman Coulter Inc.

Product

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

Status

Terminated

Initiated

2021-08-05

Posted

not on file

Terminated

2023-06-01

Reason

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

Root cause

No Marketing Application

Action

On 08/06/2021, the firm sent an initial "URGENT MEDICAL DEVICE RECALL" Notification informing its customers that due insufficient evidence the firm was not issued an Emergency Use Authorization for its SARS-CoV-2 IgG (1st IS) assay and required to discontinue distribution and to recall all affected products. On 09/13/2021 the firm sent a revised "URGENT MEDICAL DEVICE RECALL UPDATE" to inform its customers about the potential risks/harms related to using the affected products, such as, the assay may generate discordant results such as false positive, false negative or misinterpreted results when compared to other World Health Organization (WHO) traceable assays. Customers are instructed to: 1. Immediately discontinue using the Access SARS-CoV-2 IgG (1st IS) assay. 2. Discard all Access SARS-CoV-2 (1st IS) reagent packs, calibrators, and quality control. 3. A retrospective review of patient test results obtained with the Access SARS-CoV-2 IgG (1st IS) assay is not required. Any review is left to the discretion of the Laboratory Medical Director. 4. Share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. 5. If any of the affected products have been forwarded to another laboratory, provide them with the notification. 6. Complete and return the Customer Response Form within 10 days electronically via email or manually via mail 7. For credit for the affected products, complete the Customer Response Form For questions, contact Customer Support Center via: Website - http://www.beckmancoulter.com Phone - 1-800-854-3633 in the United States

Quantity

303 kits (U.S.) and 964 kits (O.U.S.)

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.

Lot, serial or model codes

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;

510(k) numbers

not on file

PMA numbers

not on file

Product code

QKO

Firm FEI

2050012

Firm city

Brea

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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