Z-1905-2021Class II

Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744

Name: Z-1905-2021 Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
Creator: Beckman Coulter Inc.
Published: 2021-05-07
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-05-07 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744 on 2021-05-07. FDA classified it as Class II and gives the reason as "SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1905-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-07
Posted: 2021-06-21
Terminated: 2023-03-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
Product code: QKO Reagent, Coronavirus Serological
Reason for recall: SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values.
Root cause tag: software
FDA root cause: Software Design Change
Action: On May 7, 2021, Beckman Coulter issued an "URGENT MEDICAL DEVICE RECALL" to affected consignees. The notification was emailed and sent via First Class Mail. In addition to informing consignees about the recall, the firm ask consignees to take the following actions: 1. Do not install any of the APF/AAF versions listed in the table. 2. Determine your current APF/AAF version. " From the Main Menu: select Configure F8 System Setup F1 System Revisions F1. " Verify the APF/AAF version displayed on the screen. 3 If the APF/AAF version is listed in the table: " Stop using the Access SARS-CoV-2 IgG II assay. Contact the Beckman Coulter Customer Technical Support Center at 1-800-854-3633 for further instruction. " Review all Access SARS-CoV-2 IgG II patient test results from April 13, 2021 onward. " Do not install any additional APF/AAF versions prior to contacting Beckman Coulter. 4. If the APF/AAF version is lower than those listed in the table, you are not impacted. Continue operating your system under existing instructions. 5. 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. 6. 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. 7. 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.
Quantity in commerce: 13,337 units
Distribution: US: Alabama, Alaska, Arizona, Arkansas, California, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, West Virginia, Wisconsin, Wyoming, OUS: Andorra, Austria, Croatia, Czech Republic, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Jordan, Poland, Portugal, San Marino, Slovakia, Slovenia, Spain, United Arab Emirates
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1905-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1905-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21
Z-1906-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-21

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)