Beckman Coulter Inc. ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
Brand
Beckman Coulter Inc.
Lot Codes / Batch Numbers
Catalog Number: C58964 UDI Code: 15099590738662 Lot Number: 922407
Products Sold
Catalog Number: C58964 UDI Code: 15099590738662 Lot Number: 922407
Beckman Coulter Inc. is recalling ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immu due to The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026