Z-2508-2021Class II

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

Name: Z-2508-2021 Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2...
Creator: Beckman Coulter Inc.
Published: 2021-08-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-08-05 / Terminated

FDA source

Beckman Coulter Inc. began a recall of 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... on 2021-08-05. FDA classified it as Class II and gives the reason as "Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2508-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-05
Posted: 2021-09-22
Terminated: 2023-06-01
Recalling firm: Siemens Healthcare Diagnostics 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
Product code: QKO Reagent, Coronavirus Serological
Reason for recall: Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute
FDA 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 in commerce: 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.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2508-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2508-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-22

Product code QKO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)