FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;
- Recall number
- Z-2257-2021
- Recalling firm
- Beckman Coulter Inc.
- Product
- ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;
- Status
- Terminated
- Initiated
- 2021-07-01
- Posted
- not on file
- Terminated
- 2023-06-14
- Reason
- SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
- 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
- 544 units
- 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
- Lot, serial or model codes
- All Lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKP
- 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