Z-0875-2021Class II

ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 -

Name: Z-0875-2021 ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 -
Creator: Beckman Coulter Inc.
Published: 2020-12-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-12-30 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc. began a recall of ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only on 2020-12-30. FDA classified it as Class II and gives the reason as "The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0875-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-30
Posted: 2021-01-15
Terminated: 2022-09-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
Product code: QKO Reagent, Coronavirus Serological
Reason for recall: The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On or about 01/04/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification to customer via mail or email informing them that the Recalling Firm has determined that the QC kit lot includes a Quality Control value card with an incorrect QC1 standard deviation (SD) value which may lead to a QC range that is too wide for the control level. Customers are instructed to: 1) Discard the incorrect QC value card included with the affected SARS-CoV-2 IgG quality control lot. 2) Use the Access SARS-CoV-2 IgG QC value card that is included with the Recall Notification letter in place of the discarded value card. 3) Review the QC1 SD value they have implemented and update if appropriate. Evaluate prior QC1 results against the correct SD value. If they detect unsatisfactory QC1 results, evaluate their previous test results. 4) Share this information with their laboratory staff and retain the recall notification as part of their laboratory Quality System documentation. 5) if the product has been forwarded to another laboratory, please provide the Recall Notification to them. 6) Complete and return/respond within 10 days to the Recall Notification: " Electronically, if they received the communication via email. " Manually, complete and return the enclosed Response Form. The Recalling Firm's actions: -They are no longer distributing the affected lot -All future lots will include a correct QC value card. Any questions - contact Customer Support Center at: " 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: 276 units
Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, ID, IL, IN, KS,KY, LA, MD, MI, MN, MO, NC, ND, NY, OH, OK, OR, PA, Puerto Rico, SD, TX, WA, and WV. The countries of Andorra, Belgium, Brazil, Bulgaria, Canada*, Croatia, France, Germany, Hong Kong, Italy, Jordan, Mexico, Paraguay, Poland, Portugal, Romania, Spain, and United Kingdom.
Product codes and lots: Catalog Number: C58964 UDI Code: 15099590738662 Lot Number: 922407

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0875-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0875-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-27	2021-01-15

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)