FDA Medical Device Recalls (openFDA)
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 number
- Z-0875-2021
- Recalling firm
- Beckman Coulter 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.
- Status
- Terminated
- Initiated
- 2020-12-30
- Posted
- not on file
- Terminated
- 2022-09-19
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Catalog Number: C58964 UDI Code: 15099590738662 Lot Number: 922407
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKO
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28