—#188299

Product

Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;

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 #188299. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.