Recalls / —
—#188240
Product
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
- FDA product code
- QKP — Coronavirus Antigen Detection Test System.
- Device class
- Class N
- Medical specialty
- Unknown
- Affected lot / code info
- All Lots
Why it was recalled
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Beckman Coulter Inc.
- Address
- 250 S Kraemer Blvd, Brea, California 92821-6232
Distribution
- Distribution pattern
- 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
Timeline
- Recall initiated
- 2021-07-01
- Terminated
- 2023-06-14
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #188240. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.