Z-2255-2021Class II

ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713

Name: Z-2255-2021 ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713
Creator: Beckman Coulter Inc.
Published: 2021-07-01
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-07-01 / Terminated

FDA source

Beckman Coulter Inc. began a recall of ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713 on 2021-07-01. FDA classified it as Class II and gives the reason as "SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2255-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-01
Posted: 2021-08-12
Terminated: 2023-06-14
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
Product code: QKP Coronavirus Antigen Detection Test System.
Reason for recall: SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
FDA root cause: Other
Action: On 07/09/2021 Beckman Coulter issued an "URGENT MEDICAL DEVICE RECALL" to all affected consignees via email and US Postal Mail. In addition to informing consignees about the recalled device, the firm ask consignees to take the following actions: 1. Immediately discontinue using the Access SARS-CoV-2 Antigen assay. 2. Discard all Access SARS-CoV-2 Antigen reagent packs. 3. At the discretion of the Laboratory Medical Director, consider updating previous laboratory reports to indicate prior Reactive laboratory results may not be accurate. 4. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. 5. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: " Electronically, if you received this communication via email. " Manually, complete and return the enclosed Response Form. 6. If you have any questions regarding this notice, please contact our Customer Support Center: " From our website: http://www.beckmancoulter.com " By phone: call 1-800-854-3633 in the United States. " Outside the United States contact your local Beckman Coulter representative.
Quantity in commerce: 3,672 unitsin total
Distribution: US Nationwide Distribution in the states of Alabama Alaska Arizona Arkansas California Connecticut Delaware Florida Georgia Idaho Illinois Indiana Iowa Kentucky Louisiana Maine Maryland Massachusetts Michigan Mississippi New Hampshire New Jersey New York North Carolina Ohio Oklahoma Oregon Pennsylvania Puerto Rico Tennessee Texas Virginia West Virginia, Wisconsin OUS: New Zealand, Libya
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2255-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2255-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2256-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2257-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12
Z-2258-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-12

Product code QKP

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)